CAREERS

Join us as we adventure beyond conventional scientific thinking.

At Synthekine, we believe our open mindset — questioning dogma and constantly re-examining the data — is instrumental in discovering and developing transformative medicines. See what it’s like to be a member of the Synthekine team.

We’re built on a foundation of trust and collaboration.

“One one of the main draws of Synthekine is that I can just walk down the hall and ask what other teams are doing, see what they’ve been doing for the past couple of days and meet formally together to have open, collaborative conversations about ongoing projects. Although we are in an industry setting and corporate setting, it’s very close to academics in the sense that we still care about the science, we still try to publish, and then we still try to get peer reviews of other people’s advice. That’s really important to me, and it’s a key component of my personal growth at this company.”

— Meng

We’re invested in our team.

We’re intentional about providing our team members personalized opportunities for learning and growth in a results-oriented culture, which supports flexibility and values fairness and diversity. We are transparent with and accountable to each other.

We like to have fun.

“Taco Tuesday’s at Synthekine is everybody’s favorite – not just because there are good tacos, but you get to be outside and catch up with your colleagues. Sometimes it’s the immediate people you work with every day or folks from other departments – it’s fun and a great opportunity to meet new people.”

— Vic

Values

Our values underpin how we operate as a company and how we show up for one another each and every day.

Integrity

We act in the best of interests of our stakeholders, team members and the patients we serve. We are ruthlessly honest with ourselves about our data, and we are trustworthy — even when no one is watching.

Innovation

We pursue breakthrough science with urgency, rigor and fearlessness.

Inclusion

We actively seek out and respect diverse perspectives so that we can learn from one another, improve together and ultimately achieve greater impact.

Teamwork

We rally around a common set of company goals, and collaborate to achieve these goals in the most effective ways possible. We are committed to one another’s success and development.

Accountability

We take and recognize ownership of the work we perform and the results we generate, including how we communicate about it. We are collectively responsible for our success.

Execution

We don’t leave implementation to chance. We are results-obsessed, work with urgency and are committed to doing whatever it takes.

Benefits

We offer a comprehensive compensation and benefits package.

Health and Fitness

  • Medical, Dental, Vision
  • One Medical Membership
  • Free On-Site Gym Access
  • Health Savings Account with Employer Contributions
  • Flexible Spending Account
  • Employee Assistance Program
  • Paid Time Off, Holidays (including paid winter break), and New Parent Leave

Financial Benefits

  • Group Life and AD&D Insurance
  • Voluntary Life and AD&D Insurance
  • Short-Term and Long-Term Disability Programs
  • 401(k) Savings Plans

Additional Programs

  • Free Shuttle Service
  • Free EV Charging Stations
  • Commuter Benefits
  • Employee Discount Programs
  • Taco Tuesday Lunches
  • Social Events (e.g. Happy Hours, summer outings)

Open Positions

Are you interested in pursuing excellent science, working alongside some of the brightest minds in the field, and being part of a team that is fundamentally shaping medicine today? Then you’ve come to the right place. Explore our open positions here at Synthekine below.

Contact: careers@synthekine.com

NOTE TO RECRUITERS AND EMPLOYMENT AGENCIES:

All of our open positions are managed through our Human Resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Synthekine, will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Administrative

Business Development

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential.  Synthekine was formed in 2019 and has raised $190M from leading biotech investors.   We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets.  Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Synthekine is seeking a Senior Manager/Associate Director of Business Development. This role reports directly to the VP of Business Development and will work closely with other management team members on a wide range of business development activities, including the identification, evaluation, diligence and execution of strategic collaborations and licensing agreements across Synthekine’s portfolio. This individual will be integral in supporting buy-side and sell-side transactions and implementing the long-range business development strategy and associated business development processes. This position will require strong business acumen, excellent interpersonal skills, and comfort interacting with both internal and external company stakeholders.

Key Responsibilities: 

  • Works cross-functionally with stakeholders across the Company (e.g., R&D, Clinical, Finance, Legal, etc.) to understand and support key strategic goals of the Company and their associated partnering / licensing activities
  • Works in close partnership with R&D and Clinical teams to create and deliver impactful presentations to potential partners in support of business development
  • Helps to source, establish, and maintain relationships with external targets aligned to partnering opportunities
  • Leads the research and analysis of licensing and acquisition opportunities, including comps, case studies, and valuation models
  • Gathers competitive and partner intelligence and communicates key insights
  • Contributes to deal structuring / term sheet development through financial analysis of economics
  • Coordinates due diligence processes with guidance
  • Supports in negotiations and execution of definitive agreements with guidance
  • Aids in preparing presentations for senior management and Board of Directors
  • Provides project management oversight to track status of partnering opportunities
  • As necessary, attends BD meetings at partnering conferences and scientific congresses
  • Represents Synthekine with a high level of business integrity while adhering to all Company policies and procedures

Requirements

  • BA, BS or equivalent required; MBA, MD, PhD or PharmD preferred
  • 8+ years (or 10+ years for Associate Director level) of relevant experience in biotech or pharmaceutical companies or in life sciences focused management consulting, investment banking, private equity, or venture capital
  • Expertise in quantitative and qualitative research and analyses, including firm grasp of financial modeling/valuation and generation of business cases
  • Excellent communication skills and the ability to collaborate successfully with varied audiences, internal and external
  • Must be a driven, highly organized self-starter with comfort working in a fast-paced environment and able to prioritize across multiple projects and deliver consistent high-quality output
  • Position requires a great deal of independence and attention to detail
  • Familiarity with or curiosity for drug discovery and development process
  • Adequate understanding of industry trends, competitive environment and commercial marketplace

Ideally, previous direct experience in a business development role that includes either search/evaluation or transaction experience

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

#LI-JS1

Clinical Operations

Company Description:

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position:

The Clinical Trial Manager manages overall operation of one or more clinical studies including project planning, budget, resource management, and management of contract research organizations (CROs) and other key vendors. Ensures compliance with company SOPs, GxP, and regulatory guidelines. Recommends and implements innovative ideas to impact clinical trials management. Coordinates with departmental and corporate management to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders. Oversees clinical trials staff both internally and at service providers and manages all aspects of study operations. Acts as a cross-functional liaison to ensure study plan appropriately supports research questions and other goals of the company as needed. Ensures a positive, collaborative team environment and escalates issues to the supervisor(s) as appropriate.

Responsibilities:

  • Leads all efforts in support of 1-4 clinical research protocols (depending on size and complexity) from protocol design to final deliverables, in accordance with specified timelines, budgets, and associated corporate goals.
  • Participates in the assessment and selection of CROs, sites, and other vendors; may perform site or vendor qualification visits, request, and review proposals, and provide input on task orders and/or other project specifications.
  • Acts as primary point of contact for CROs and other vendors as needed. Represents the company on periodic vendor calls, with or without management oversight, and ensures CRO personnel adhere to project specifications with particular attention to timelines, costs, and quality of deliverables.
  • Coordinates critical decisions among key stakeholders including Synthekine personnel, scientific advisers, and vendor representatives. Escalates issues appropriately.
  • Ensures that participating investigators adhere to GxP and applicable regulations by reviewing monitoring visit reports and direct engagement in direct communication with CRO personnel and Synthekine CQA or designee. Identifies and escalates any significant compliance issues to management.
  • Takes personal responsibility for ensuring regulatory compliance and delivery of high-quality data via all appropriate means. Develops and exhibits facility with data management software as required to review clinical data and associated metrics, and address data quality issues directly with CROs and sites as needed.
  • Assists with national regulatory and IRB/Ethics Committee submissions and responses to questions as required.
  • Reviews and contributes to Clinical Study Reports, INDs, BLAs, and other clinical and regulatory documents.
  • Represents the company as needed at professional meetings and presents clinical operations materials and provides training at such events as needed.
  • Provides ongoing assessment and feedback on departmental policies and procedures toward increased efficiency and quality of deliverables. May contribute to the development of SOPs and other procedural documents.
  • Develops metrics and reports as needed in conjunction with vendors, other clinical operations personnel, and Synthekine functional leads. Summarizes and presents these data as required.

Qualifications:

  • Bachelor’s degree, preferably in a scientific or health-related discipline.
  • Minimum of 6 years of clinical and related experience with at least 2 years of clinical trial management experience in an industry setting such as a CRO or pharmaceutical company. Trial management experience gained at academic or other not-for-profit institutions involved in industry-sponsored research may supplement this requirement at the discretion of the hiring manager.
  • Excellent understanding of GxP, ICH, FDA, EMA etc. regulations.
  • Clinical experience/background (e.g., RN, PA, or medical office) also a plus.
  • Demonstrated ability to develop positive working relationships with individuals and teams both inside and outside the company.
  • Must have proficiency with MS Office as well as demonstrated ability to learn other project management and clinical trial software as required.
  • Demonstrated ability to work independently, escalate issues appropriately, and to ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality.

WORKING CONDITIONS:

  • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
  • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Ability to travel approximately 20%-50%, depending on departmental needs.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Clinical Development

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Synthekine is seeking a Medical Director of Clinical Sciences to join an exciting and dynamic start-up environment to manage the clinical development research studies for our cell therapy programs including phase I-IV studies. The Medical Director will have oversight, execution, and management of clinical trials for our innovative pipeline of early-stage T cell therapies. This individual will have a strong understanding of drug product development including clinical trial management, IND, and NDA submissions, medical monitoring, and GCP principles.

Key Responsibilities:

  • Participate in and/or lead cross-functional project teams to design and implement clinical studies.
  • Provide expert opinion and writing support for trial-related documents including protocols, investigator brochures, charters, clinical study reports and review of clinical trial documents.
  • Define clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications.
  • Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
  • Collaborate with Clinical Operations to expedite execution of clinical trials
  • Help devise and execute development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
  • Translate findings from research and nonclinical studies into clinical development opportunities.
  • Represent Synthekine in external scientific and medical forums.
  • Work with internal teams and to apply regulatory guidelines relevant to the biotech industry and ensure compliance with these external guidelines.
  • Work with internal discovery scientists, translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, external consultants or CROs in a cross functional manner.

Requirements:

  • MD with at least 3 years of experience (or 5+ years for Senior Medical Director) in the biotech industry with a track record in all phases of development, from first in human to pivotal, and to phase IV
  • Board certification in Oncology is desirable
  • Strong track record in cell therapy clinical trials, experience in early phase trials preferred
  • Experience in the development of immuno-therapeutics in Oncology
  • Demonstrated ability to independently evaluate, interpret, and present complex scientific data
  • Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, and clinical pharmacology)
  • Demonstrated ability to work cross functionally with a multi-disciplinary team of peers and outside experts
  • Experience participating in FDA document preparation, ideally with FDA interaction
  • Ability to work in a fast-paced, start-up environment
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Ability to work independently and as part of a team
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Demonstrated scientific productive (publication, abstracts, etc.)

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Finance/Accounting

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential.  Synthekine was formed in 2019 and has raised $190M from leading biotech investors.   We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets.  Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

The Accounting Manager will be a key contributor to the Finance function and the Synthekine organization in general. This position will work closely in collaboration with the rest of the Finance Team to complete the monthly financial close and assist with other responsibilities during quarter-end. This position will be the primary owner for several general accounting areas, such as cash, fixed assets, prepaids, other general assets and liabilities and expense accruals. The position will partner with the Accounts Payable and the Procurement functions to oversee and perform key internal control and procedural activities.

Partnering with the rest of the Finance Team, this position will also play an active role in performing and supporting SOX internal controls, and in completing our periodic reviews and audits by our external auditors, KPMG.

Key Responsibilities: 

  • Assist in managing the month-end close process, variance analysis and documentation to support performance of required SOX internal control procedures.
  • Prepare journal entries and balance sheet reconciliations for cash, prepaid expenses, fixed assets, other assets and certain operating expense accruals
  • Comply with proper SOX internal control procedures, and support regular testing of controls as part of SOX 404 requirements
  • Support the external quarterly reviews / annual audit processes including the preparation of “prepared by client” (PBC) requests, interactions with the auditors and resolution of open items.
  • Assist with certain periodic compliance filings, such as quarterly use tax filing, the Form 571-L property tax filing, etc.
  • Partner with the Accounts Payable function to ensure performance of AP internal controls and operational activities, such as invoice vouchering and the payment run processes.
  • Partner with the Procurement function to oversee the Company credit card program, and ensure proper accounting of monthly activities.
  • Assist with documentation, implementation, and maintenance of corporate accounting policies and procedures.
  • Contribute to new ERP system implementation project in design, configuration, testing and other implementation procedures related to the accounting and financial reporting processes.
  • Perform ad hoc projects and/or assist other Finance Team members, as deemed necessary.

Qualifications

Minimum qualifications:

  • Bachelor’s degree with emphasis in Finance and/or Accounting
  • Minimum of five years of relevant work experience
  • Strong Microsoft Word skills in Excel and MS Word.
  • Strong oral and written communication skills
  • Solid core accounting knowledge
  • Ability to work effectively within a team that requires good coordination and collaboration to complete team and company objectives.
  • Ability to effectively work cross-functionally
  • Proactive, detail-oriented, a self-starter, able to take responsibility and maintain high quality and accuracy in reporting with specific deadlines.
  • Results oriented with an ability to manage work appropriately to meet deadlines.
  • Flexible and able to adapt to growing organizations and deal with the Company’s frequently changing needs and priorities.

Preferred qualifications:

  • Certified Public Accountant
  • Biopharmaceutical industry experience
  • Public Accounting / Big 4 experience

Apply here.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Program Management

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

An ideal candidate for this position will be an experienced Project Management professional with demonstrated ability to manage drug development projects from research through IND-enabling studies to Phase 2 proof-of-concept, including CMC. Reporting to the Vice President of Program Management, this individual will work closely with the project leader and cross-functional teams to define project strategy to meet corporate goals, develop integrated project plans, and implement plans to meet business objectives.

Key Responsibilities: 

The successful candidate will draw upon their experience to:

  • Develop and issue timely meeting agendas and minutes, facilitate project team meetings and follow up on action items, ensure effective cross-functional communication and decision making to maintain alignment between key internal and external stakeholders.
  • Communicate, document, and archive project team activities, meeting materials and decisions, act as a primary contact for project team related information.
  • Develop and manage project scope, deliverables, risks & resources requirements in partnership with respective functional business partner including:
    • Scheduling building, tracking, management, and communication
    • Budget management
    • Risk management
  • Establish and maintain functionally integrated project plan (goals, key objectives, deliverables, risks) and timelines to enable accurate project, financial and portfolio analyses for business planning processes.
  • Oversee and prepares project team budget including key deliverables and assumptions to support project plan, resources and costs collaborating with Finance and other cross-functional departments.
  • Identify, recommend, and implement opportunities for streamlining team and business processes.
  • Partner with the team leader to ensure the team achieve and maintains a high-level of sustainable performance, by applying appropriate team management best practices.
  • Participate in establishment of project team system guidance, best practices, and implementation.
  • Support new corporate development activities or other initiatives performing tasks as required supporting department, portfolio or corporate needs.

Requirements:

Ideal candidate will have the following experience and be able to demonstrate the following:

  • B.A. or BSc. in Life Sciences (MSc., MBA or Ph.D. a plus) and at least 12 years’ experience in the biotech/pharmaceutical industry with at least 5 years’ direct development project management managing cross-functional teams.
  • PMP (Project Management Professional) or other PM certification or equivalent a plus.
  • Outstanding verbal and written communication skills and the ability to effectively interact with all levels within the company including internal partners and functional areas.
  • Excellent interpersonal skills, including clear, succinct, and timely communication.
  • Ability to develop and foster important relationships with key stakeholders as well as to utilize strong conflict management skills.
  • Ability to summarize complex information into simple concepts for broad communication to project teams as well as for management status reports.
  • Broad knowledge of the drug development process, coupled with strong proficiency in project management practices, tools, and methodology.
  • Excellent analytical skills with an ability to communicate complex issues.
  • Ability to translate strategy into action; strong influence, negotiation, and presentation skills.
  • Proven track record of good decision making and exercising sound judgment.
  • Experience using Project Management software to manage complex project timelines and resources.
  • Proven ability/expertise to influence internal teams to achieve project goals.
  • Experience building, managing, and articulating comprehensive, complex, cross-functional plans.
  • Strong computer proficiency with MS Word, MS Excel, MS PowerPoint, Microsoft Teams, Smartsheets

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Regulatory Affairs and Quality

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Reporting to the Senior Vice President of Technical Operations, the Vice President of QA/QC will lead, direct, and develop the Synthekine Quality organization. This position will provide strategic guidance to senior leadership in the development, adoption, communication, and training of all employees and external contractors/vendors regarding corporate GxP quality practices/standards, and setting the expectation of compliance by following strict quality standards throughout clinical product development and production. The role will serve as a subject matter expert and resource to corporate functions for interpretation of FDA and regulatory agency regulations and guidelines, as well as corporate standards and policies related to GxPs.

Key Responsibilities:

  • Guides and supports senior leadership in identifying a quality strategy and developing supporting policies.
  • Provides systems support and quality operations to ensure compliant drug development and manufacturing, regulatory communications, and clinical and ultimately commercial distribution.
  • Establishes a foundation of quality in all GxP operations, in support of manufacturing, clinical development, pharmacovigilance and regulatory affairs.
  • Ensures consistent application of quality standards through the development of Standard Operating Procedures (SOPs), with the preparation and maintenance of the SOPs overseen by the Quality organization.
  • Plans and conducts/coordinates GxP (GCP, GLP, GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines and within budget, as necessary.
  • Plans, schedules, prepares for, conducts, reports, and closes out all audits undertaken. This may include, but is not limited to, audits of clinical study documents (protocols, amendments, informed consent, clinical study reports, advertisements), Project set-up, Project In-Life, Investigator Sites, databases, study reports and sub-contractors.
  • Assures that Quality is present in all manufacturing validation and all regulatory documentation.
  • Serves as a liaison with the FDA and regulatory agencies.
  • Oversees and manages all quality and compliance issues, ensuring appropriate CAPA (corrective and preventive action) plans are defined and implemented.
  • Advises senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues.

Requirements:

  • Bachelor of Science (B.S.) degree or equivalent in experience.
  • 15-20 years of quality or technical experience within the pharmaceutical or biotechnology industry
  • Demonstrated success as a Quality organizational leader, with the ability to lead, direct and develop members and build a Quality organization.
  • Experience in a smaller pharma/biotech which has reached commercial stage is ideal.
  • Demonstrated success in evaluating quality compliance issues in all phases of clinical development, followed by a recommendation for effectively resolving the business challenge.
  • Direct experience and a positive record of performance when presented with a health authority inspection.
  • Extensive knowledge of the pharmaceutical research and development process, specifically clinical development, regulatory, and drug submission requirements.
  • Broad knowledge of and experience applying compliance regulations.
  • Familiar with quality management systems and document control systems, including database creation, utilization, and maintenance.
  • Previous experience in establishing GxP (Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)) quality guidelines and FDA regulations compliance.
  • Able to respond to inquiries or complaints from regulatory agencies.
  • Ability to read, analyze and interpret scientific information and reports, technical journals and legal documents.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

The Vice President of Regulatory Affairs is responsible for developing and directing Synthekine’s regulatory strategy, objectives, policies, and programs from IND planning through NDA and future commercialization. This position will serve as the regulatory lead for Synthekine developing and providing strategic regulatory direction and guidance to R&D on corporate projects and key strategic business initiatives to achieve corporate objectives. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including CMC, discovery, preclinical, and clinical. The Vice President, Regulatory Affairs will report to the Chief Medical Officer and will work with cross functional teams including Development, QA, Clinical, and Business Development.

Key Responsibilities:

  • Act as primary strategic contact with the FDA and other regulatory agencies, as applicable, to enable execution of company regulatory goals
  • Lead the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents (INDs, NDAs, CTAs, MAAs, supplemental NDAs, and other relevant regulatory filings) working in close collaboration with technical operations, clinical, nonclinical and legal groups
  • Lead in the preparation and assembly of clinical submissions for regulatory agencies (protocols, informational amendments, annual reports and safety reports)
  • Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities
  • Build and manage Regulatory team including external consultants based on the stages of the business
  • Develop and design robust regulatory organization, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy
  • Provide expertise in the interpretation, guidance and training of FDA regulations and regulatory advice to other functional groups and executive management
  • Troubleshoot and resolve regulatory management and scientific issues on projects as required in collaboration with functional groups

Requirements:

  • Bachelor’s degree in a scientific discipline or equivalent. Advanced degree preferred (MS, PhD, PharmD, MD)
  • At least 15 years of experience in pharmaceutical/biotechnology industry, of which a minimum of 10 years in Regulatory Affairs with leadership and/or management experience
  • Extensive experience working with the FDA and other Regulatory Authorities, with proven successful NDAs (recent experience preferred) and equivalent international regulatory submissions highly desired
  • Experience with preparation and conduct of FDA advisory committee meetings preferred
  • Experience and/or active involvement in joint ventures, highly collaborative partnerships, and in/out-licensing business opportunities is a plus
  • Experience supporting commercialization is a plus
  • Strong leadership and organizational skills as well as strong strategic and analytical abilities, diplomacy, negotiation, and excellent oral and written communications skills
  • Writing skills that meet regulatory requirements and standards for documentation, including the ability to effectively describe complex situations
  • Strong understanding of the global pharmaceutical drug development and regulatory environment particularly within the FDA
  • Ability to communicate effectively, build cross-functional relationships, and work collaboratively with other groups
  • Must be comfortable in a small company environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Research and Development

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are seeking a Scientist/Senior Scientist for our In Vivo Pharmacology and Translational Medicine department. Title and responsibilities are commensurate with candidate qualifications. This individual will contribute to our company’s goal to utilize cutting edge protein engineering to enhance the immune response against various diseases. Specifically, you will help support the in vitro and in vivo characterization of cell therapies that incorporate an orthogonal IL-2 cytokine-receptor that selectively enhances the efficacy of engineered cellular immunotherapies in various pre-clinical tumor models (Sockolosky et al. Science 2018, Aspuria et al. Science Translational Medicine 2021).

For the key responsibilities/requirements:

  • Characterize engineered mouse and human T cells with in vitro assays (including cytotoxicity, cytokine release, cell proliferation, cell signaling, and immunophenotyping)
  • Manufacture engineered mouse and human T cells
  • Help design and execute pre-clinical anti-tumor studies to demonstrate efficacy and characterize mechanism of action of orthogonal IL-2 cytokine-receptor T cells in immunocompetent and immunocompromised mouse models of cancer
  • Help perform in vivo tumor implants, caliper measurements, bioluminescent imaging, dosing, and collect blood and tissue for downstream analyses.
  • In vivo characterization of modified T cells by multi-color flow cytometry
  • Perform biomarker assessment and pharmacodynamic characterization (e.g. bead based cytokine quantification, ELISA)
  • Generate, collect, analyze and present experimental data in team meetings
  • Work and manage multiple projects simultaneously

Qualifications:

  • Scientist: PhD degree in immunology or related fields, M.S. degree in immunology or related fields with 2+ years of experience in the immunology/immunotherapy field, or B.S. degree in immunology or related fields with 5+ years of relevant experience, preferably in a biotech setting.
  • Senior Scientist level: PhD degree in immunology or related fields with 5+ years of experience in the immunology/immunotherapy field, M.S. degree in immunology or related fields with 7+ years of experience in the immunology/immunotherapy field, or B.S. degree in immunology or related fields with 9+ years of relevant experience, preferably in a biotech setting.
  • Excellent knowledge of immunology and immunotherapy fields, specifically adoptive T cell therapies
  • Experience with immune cell-based assays including cytotoxicity assays, cell proliferation assays and ELISAs
  • Experience with multi-color flow cytometry and data analysis (FlowJo)
  • Expertise in aseptic techniques for cell culture and cell isolation
  • Experience with pre-clinical anti-tumor studies to evaluate T cell function in vivo
  • Experience with mouse handling techniques including tail-vein, intraperitoneal, and sub cutaneous dosing of small molecules, adoptive cell transfer, and tissue harvesting
  • Proficiency in Excel, PowerPoint, Prism, and other programs to create and distribute reports
  • Excellent problem-solving and time management skills
  • Strong organizational and record keeping skills
  • Effectively able to communicate plans and results in both oral and written form
  • Ability to work in a fast paced and highly dynamic collaborative team environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are looking for a highly motivated Scientist/Sr Scientist with expertise in phage and/or yeast display technologies to expand our antibody engineering capabilities. The Scientist/ Sr. Scientist will be responsible for running single domain antibody discovery campaigns and for supporting other antibody engineering projects such as humanization, domain mapping, and fine epitope mapping.

Key Responsibilities:

  • Generate and screen single domain antibody libraries
  • Develop and execute high throughput binding screens such as ELISA or multiplex flow cytometry for lead generation
  • Facilitate the identification of a lead panel of antibodies utilizing HTS, sequence analysis, and affinity ranking
  • Troubleshoot scientific and technical challenges
  • Contribute towards the engineering of lead antibody sequences to improve developability
  • Present data and updates to project teams
  • Maintain good record keeping in an electronic lab notebook

Requirements:

  • PhD and a Postdoc working on related projects with 5+ years of experience for Senior Scientist level (0-2 years for Scientist I level or 2-5 years for Scientist II level) or MS with 7+ years of industry experience
  • Experience in phage/ yeast display with strong competence in at least one display system
  • In-depth molecular biology experience, especially in library construction and repertoire analysis by NGS
  • Strong background in mammalian cell culture, multiplex flow cytometry and FACS sorting
  • Working knowledge of antibody analysis software/ programs
  • Team player with excellent verbal and written communication skills

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Company Description:

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Synthekine is seeking a motivated and energetic Research Associate to support the Mammalian Cell Culture group within the Department of Protein Sciences at our Menlo Park, CA location.

The candidate will support protein production for multiple pre-clinical research programs, utilizing multiple mammalian expression platforms at various scales. Furthermore, the position will be responsible for expanding our protein expression capabilities, helping to develop an automated high throughput expression platform and supporting the implementation of stable cell line expression systems.

A successful candidate is self-motivated with a desire to learn new methodologies, implement new technology and eager to contribute to our research and development projects. The individual will be part of a highly collaborative and fast growing, dynamic startup team that supports pre-clinical research in oncology, cell therapy and immunology.

Key Responsibilities: 

  • Maintaining multiple mammalian cell lines (continuous culturing, scale-up, freeze-thawing).
  • Weekly transfections/expression-harvests at different scale and in different cell lines
  • Establishing, maintaining and utilizing liquid handling robot for high throughput expression
  • Establishing/utilizing a mammalian stable expression platform

Qualifications:

  • Bachelor (BA or BS) degree in a relevant scientific discipline.
  • 2-4 years (0-2 years for Research Associate I level) of hands-on experience in mammalian cell culture (stable and transient expression)

Hands-on experience with automated liquid handlers a plus

Apply here.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are seeking an experienced and collaborative in vivo immunologist to join our In Vivo Pharmacology and Translational Medicine group as an Associate Director or Director. Title and responsibilities are commensurate with candidate qualifications. In this role, you will contribute to our company’s goal to utilize cutting edge protein engineering to modify the immune response in cancer and/or autoimmune / inflammatory diseases to benefit patients.

Key Responsibilities: 

  • Design and coordinate the execution and analysis of pre-clinical tumor immunology and / or autoimmune disease studies to evaluate efficacy and mechanism of action of our engineered cytokines
  • Design, execute and analyze pharmacodynamic and toxicology studies
  • Expert knowledge to direct the immune cell analysis from in-vivo and in-vitro experiment by flow cytometry, gene expression and functional assays
  • Design and guide biomarker assessment, such as MSD and bead-based cytokine quantification, gene expression analysis such as 10x and Nanostring
  • Develop and set-up new mouse tumor immunology or/and autoimmune disease models as needed
  • Interface with multiple projects and teams across the organization to advance our programs
  • Become the in vivo program lead for one of our programs
  • Accomplish goals under project team timelines
  • Support, teach and mentor co-workers as needed

 

 

 

Requirements:

  • PhD degree in immunology or related fields with 10+ years of experience (12+ years for Director level) in the tumor immunology, autoimmunity or immunotherapy field, preferably in a biotech setting.
  • Experience in leading and managing direct reports
  • Excellent theoretical knowledge of T cell immunity and hands on experience with mouse models for tumor immunology or/and autoimmune disease models such as colitis, arthritis and EAE including cell isolation from target organs for downstream analysis
  • Experience with multi-color flow cytometry and data analysis (FlowJo or similar)
  • Experience with immune cell-based assays including cytokine secretion assays, cell proliferation assays and ELISAs
  • Experience with the analysis of single cell sequencing data (10x Genomics or similar)
  • Expertise in aseptic techniques for cell culture and cell isolation
  • Experience with mouse handling techniques including tail-vein, intraperitoneal, and subcutaneous dosing of biologics
  • Proficiency in Excel, PowerPoint, Prism, and other programs to create and distribute reports
  • Excellent problem-solving and time management skills
  • Strong organizational and record keeping skills
  • Effectively able to communicate plans and results in both oral and written form
  • Ability to work in a fast paced and highly dynamic collaborative team environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Company Description:

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position:

Synthekine is looking for a driven & talented Biomarker Data Analyst/Immunologist to play a key role in the analysis and assessment of proteomic and genomic data to advance Synthekine’s therapeutic programs.  The individual will have fundamental knowledge and skills in immunology and a strong understanding of computational biology.  The candidate will have a good perception of the translation oncology space including Phase 1 and 2 oncology clinical trials with knowledge of the clinical immune monitoring programs for immunotherapy drugs. This is an excellent opportunity for a candidate who is looking to build-up on experience in single cell data analysis skills by being involved in the assessment and interpretation of high-dimensional immune monitoring data and drive exploratory analysis of clinical studies.

 

Responsibilities:

  • Primarily responsible for the development and maintenance of data analysis infrastructure for all phases of the nonclinical and clinical programs. Perform flow cytometry data analysis and interpret the results accurately and timely for Synthekine’s preclinical and clinical study programs
  • Responsible to plan, evaluate and develop meaningful clinical flow cytometry data analysis that will result in graphical representation of the data and prepare data visualization slides for technical discussions and interpretation.
  • Contributes, assists, and trains members of the team in conducting single cell high dimensional data analysis from multiple data sources and participates in the performance and evaluation of big data visualization tools.

Qualifications:

  • Scientist Level: PhD in Immunology or Cell Biology, or similar fields with minimum of 3-5 years post-graduate experience in clinical immune monitoring programs; Senior Level: PhD in Immunology or Cell Biology, or similar fields with minimum of 5-8 years post-graduate experience in clinical immune monitoring programs. Persons with BS/MS degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
  • Prior experience with multi-color flow cytometry and in high-dimensional flow cytometric data analyses using targeted and unbiased software applications, such as CytoBank, or FCS Express or Flow Jo.
  • Familiarity with other assay platforms that generate deep data such as transcriptomics, proteomics, or genomics. Demonstrates strong aptitude for data analytics, mathematical and statistical concepts
  • Expertise in managing, curating, and analyzing large datasets accumulated via multiplexed, multicolor (>35, and/ or deep-data platforms (e.g., NGS or proteomics). Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
  • Expertise in statistical analyses of large datasets and creating visualizations of data via software analytic tools, such as Spotfire, Tableau, or similar tools
  • Expertise with writing/running software scripts, e.g., R or Python, or deployment of supervised/unsupervised machine-based learning algorithms to deconvolute high-dimensional analyses.
  • Bioinformatic analyses experience is desirable. Use novel computational approaches to isolate potential biomarkers from disparate data sources
  • Actively participate in presentations of Clinical translational data and scientific discussions in internal meetings. Communicate experimental findings accurately and concisely in both oral and written form.
  • Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication. Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Synthekine’s scientific and business goals
  • Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are seeking a creative Scientist in Cytokine Lead Discovery, reporting to the Director of Cytokine Biology.  This group engineers and characterizes the bioactivity of cytokines with altered functionality, tailoring the molecules for therapeutic uses in immune-oncology, autoimmune and inflammatory diseases.  We use crystal structures and in silico modeling to design modified cytokines, generate the proteins, and characterize their binding and bioactivity in multiple assays formats.  This is typically an iterative process of engineering, testing and modifying the cytokines to build a set of therapeutic candidates and mouse surrogate molecules for proof of concept studies.

The ideal candidate will be proficient with some of the following skillsets:  molecular biology, protein expression (bacterial, mammalian, insect or viral), small scale affinity purification (Ni, Protein A), screening for binding (yeast/mammalian display, ELISA, or Octet), in vitro characterization of bioactivity (FACS, or mammalian cell-based assays), HPLC (Size Exclusion Chromatography) and protein modification (pegylation or labelling).  The candidate is expected to be able to adjust to a flexible, dynamic and high-paced research environment with shifting priorities and deadlines.

Key Responsibilities: 

  • Molecular biology: design, assemble, sequence expression vectors, or oversee outsourcing.
  • Protein Biochemistry: small scale protein purification; modification of proteins (ex: pegylation, biotinylation), formulation and stability studies, analytical HPLC.
  • Tissue Culture: small scale mammalian, bacterial, or insect cells.
  • Assays: ELISA, western, cell-based assays, FACS, de novo design of basic assays.
  • Collaborate with in vivo researchers to evaluate the therapeutic potential of engineered cytokines.
  • Communicate experimental findings accurately and concisely in both oral and written form.
  • Analyze, document and report laboratory data in accordance with Synthekine’s standards and procedures.
  • Present at group meetings, project team meetings and company-wide meetings.
  • Develop data to support patent filings, and interface with intellectual property team.

 

Requirements:

  • Scientist I level: PhD in Immunology, Cell Biology, Biochemistry, or relevant field with 0-2 years of industry experience (or Master or Bachelor’s degree with 2-5 years of industry experience)
  • Scientist II level: PhD in Immunology, Cell Biology, Biochemistry, or relevant field with 2-5 years of industry experience (or Master or Bachelor’s degree with 5-7 years of industry experience)
  • Experience and knowledge of molecular biology, protein expression and yeast display.
  • An understanding of the structural underpinnings of designer cytokines.
  • Expertise in the fields of immunology and/or cell biology.
  • Ability to independently design, plan and execute and interpret experiments.
  • Ability to organize and communicate complex data sets in a clear and concise manner.
  • Excellent organization and planning skills, the ability to work in a fast-paced entrepreneurial environment, good verbal skills and written communication, and strong motivation with a dedicated work ethic.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-JS1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets for the treatment of cancer, autoimmune and inflammatory diseases. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are seeking an experienced, highly motivated, and creative world class immunologist to lead the In Vivo Pharmacology and In Vivo Translational Medicine group. Reporting to the Chief Development Officer, this role will lead the in-vivo exploration and development of our company’s novel approaches to modify the immune response in cancer and autoimmune diseases to benefit patients. This position will be able to utilize the products of our cutting edge protein engineering to achieve this goal.

The successful candidate will assume primary responsibility for nonclinical safety/toxicology, exploratory and developmental pharmacology, with the scope of responsibility extending to regulatory support through IND submissions. Prior relevant experience and a successful track record of strategic planning, execution, and employee development are a must.

Key Responsibilities:

  • Provide strategic insight and technical leadership and expertise for In Vivo function
  • Lead and oversee the design, execution and analysis of pre-clinical autoimmune disease, inflammatory and tumor immunology studies to evaluate efficacy and mechanism of action of our engineered cytokines and surrogate cytokine agonists
  • Lead the design, execution and analysis of pharmacodynamic and toxicology studies
  • Guide the analysis and interpretation of immune responses by multicolor flow cytometry, gene expression and functional assays including cytokine quantification, gene expression analysis including as single cell transcriptomics
  • Support new product selection activities in the company, along with technical diligence associated with partnering and co-development agreements
  • Lead the development and set-up new mouse autoimmune and cancer models as needed
  • Experience with syngeneic tumor models or humanized mouse models is a plus
  • Interface with multiple projects and teams across the organization to advance our programs
  • Lead and co-lead one or several of our development programs
  • Accomplish goals under project team timelines
  • Support, teach and mentor co-workers

Requirements:

  • PhD or MD degree in immunology or related fields with 15+ years of biologic drug discovery experience, preferably in a biotech setting.
  • Excellent theoretical knowledge and documented scientific leadership in mouse autoimmune disease models such as colitis, arthritis diabetes or EAE or/and tumor immunology
  • Deep knowledge of immunology (cells, signaling, and pathways) and documented record of achievement in the field of immunology
  • Proven leadership and team management skills
  • Experience with cytokine and/or antibody therapeutics discovery and development
  • A high affinity for leading edge technologies, and the ability and desire to collaborate with a highly diverse, cross functional team
  • Experience leading a team of scientists to accomplish highly ambitious goals to even more ambitious timelines
  • Ability to embrace rapidly changing priorities and challenges
  • Strong experimental design skills
  • Able to relocate to the San Francisco Bay Area
  • Strong communication, computer, collaboration, organizational, time management, and problem-solving skills

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Technical Operations

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

As process engineer for cytokine biologics, you will support technology transfer, process characterization and validation, continuous process improvement, and general manufacturing operations for Synthekine’s clinical stage cytokine biological molecules. The candidate will be hands-on with in-house processing activities as well as providing technical lead for CMO process transfer and manufacturing work. The position will have the opportunity to cover a wide variety of manufacturing areas, including upstream fermentation, downstream purification, drug product fill and finish, QC testing, and overall lifecycle management.

Key Responsibilities:

  • Provide technical expertise for technology transfer activities to ensure successful implementation of new products, continuous improvement changes, and scaleup processes into GMP manufacturing operations at CMO sites.
  • Accountable for maintenance of manufacturing operations, including batch record review, process performance monitoring, and technical evaluation of deviations.
  • Contribute to design of characterization and validation studies across the complete manufacturing process, including design space experiments for fermentation, refold, PEGylation, depth filtration, centrifugation, and chromatography processes as well as sterile filter validation and other drug product process validation activities.
  • Assess transferability of process changes to ensure fit for facility and impacts to manufacturing operations, process performance, equipment, raw materials, analytical testing, and other quality considerations.
  • Collaborate with internal process development and CMO partners in execution of phase appropriate process characterization and process validation studies.
  • Interface with internal and external manufacturing, QC, and QA groups to enable implementation of process changes and provide effective communication of potential impacts to relevant stakeholders.
  • Manage the generation of manufacturing documentation, GAP and risk assessment, technology transfer, process characterization, and validation reports in support of IND and regulatory filings.
  • Assist in on-site benchtop experiments and small-scale operations for E. coli and mammalian CHO expression, recovery, and purification processes.
  • Deliver written or oral reports and presentations for project progress or study results. Provides recommendations for next steps or potential resolutions to open issues or challenges.

Requirements:

  • BS degree in biochemical engineering, biology, or life sciences field with at least 2 years industry experience in biotechnology manufacturing, process development, or MSAT functions.
  • Senior level: BS degree in biochemical engineering, biology, or life sciences field with 5+ years industry experience in biotechnology manufacturing, process development, or MSAT functions (or relevant MS degree with 2+ years industry experience).
  • Hands on experience in manufacturing or process development across several unit operations for E. coli and/or CHO expressed recombinant proteins. These may include cell line development, fermentation or cell culture, TFF, centrifugation and depth filtration, refolding, PEGylation conjugation, and/or chromatography steps.
  • Proficiency with review and interpretation of QC and characterization analytical data from SDS-PAGE, HPLC/UPLC, immunoassays, bioassays, residual host cell impurities, LO, sterility, and endotoxin.
  • Strong understanding of scale-up and scale-down parameters and use of DOE for study of process design space.
  • Working knowledge of cGMP, ISO, ICH, and QBD principles and their application towards regulatory agency compliance.
  • Familiarity with drug product fill / finish operations, aseptic processing, and validation requirements.
  • Exposure to analytical characterization methods, including LC-MS intact mass and peptide map, MFI, DLS, DSC, Raman, or other biochemical and biophysical protein characterization methods.
  • Some experience with drug substance and drug product formulations, stability, forced degradation, and/or protein characterization.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are looking for a talented & driven Analytical methods Research Associate to play a key role in the development and execution of product specific assays for Synthekine’s various programs. Relevant assays will include SEC-HPLC, CEX-HPLC, RP-HPLC, ELISA, qPCR, peptide mapping, MS, LC-MS, SEC-MALS, Biacore, western blot, SDS-page, IEF, and other assays that may be required. The analytical development analyst will play a crucial role in the characterization of both clinical drug candidates and research drug candidates. Level will be commensurate with experience.

­­­­­­­­­­­­Key Responsibilities:

  • Participate in the optimization, execution, troubleshooting, qualification, and validation of biochemical assays to support characterization of Synthekine’s drug candidates
  • Work closely with members of the process development, engineering, research, and protein sciences groups to determine the best methods for solving analytical challenges and to ensure that testing needs are met
  • Troubleshoot, propose next steps, or suggest alternate strategies within complex systems and assays
  • Ordering, installation, and maintenance of laboratory instruments, equipment, and assay materials.
  • Authorship of analytical protocols, reports, and SOPs.
  • Communicate experimental findings accurately and concisely in both oral and written form
  • Analyze, document and report laboratory data in accordance with Synthekine’s standards and procedures
  • Present at group meetings, project team meetings and company-wide meetings

Requirements:

  • RA I Level: BS in Biochemistry, Immunology, or similar fields with 0-2 years of experience in an assay development environment.
  • RA II Level: BS in Biochemistry, Immunology, or similar fields with 2-4 years of experience in an assay development environment.
  • Experience with standard molecular biology techniques strongly preferred (i.e. ELISA, protein/peptide sample prep and separation, qPCR, HPLC, SDS-PAGE, IEF, Western blot).
  • Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communication
  • Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Synthekine’s scientific and business goals
  • Ability to think critically, analytically and to have strong troubleshooting and problem-solving skills based on deductive reasoning.
  • Self-motivated with the ability to work independently and collaboratively in cross functional teams
  • Excellent interpersonal, verbal and written communication skills
  • Proven ability to manage ambiguity and thrive in startup environments to build and establish new facilities, teams, and processes
  • Ability to work with a sense of urgency in a fast-paced environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

We are looking for a talented and driven Cell Therapy Process Engineer to be a core contributor to startup of Synthekine’s CAR-T (and TCR or TIL) cell therapy process development capabilities. The position will also collaborate within cross-functional project teams responsible for designing, analyzing, and optimizing cell therapy manufacturing processes for in-house execution or with CMO partners. The successful candidate will show broad aptitude towards current state of the art cell therapy equipment and processes, analytical controls, and manufacturing operations to support both early stage discovery programs and clinical through commercial manufacturing.

Key Responsibilities:

  • Establish in-house cell therapy process capabilities suitable for development, optimization and manufacture of cell therapy product meeting clinically relevant yield and quality.
  • Develop all aspects of cell therapy clinical process.
  • Assess parameter effects on process performance, establish optimal parameters and controls, design and execute phase appropriate process characterization experiments.
  • Determine cell therapy equipment design and functional specifications appropriate for current and future cell therapy programs. Perform installation and maintenance of laboratory instruments and equipment.
  • Originate and review protocols related to leukopak handling, cell isolation (MACS), activation, transformation (e.g. lentivirus), cell expansion, harvest, cryopreservation, and analytical release testing (e.g. cell count, FACS, etc.) for in-house and CMO based projects.
  • Compile and analyze data for technical reports and presentations to support process decisions and facilitate active engagement with other scientific and technical stakeholders.
  • Handle process transfer from small scale cell therapy laboratory formats to commercially feasible platforms with clinical regulatory compliance.
  • Collaborate with research and discovery teams to: (i) identify the product’s critical quality attributes for manufacturing scale and (ii) evaluate existing and new equipment to modify or develop new processes and/o r transfer to and from CMO partners.
  • Communicate experimental findings accurately and concisely in both oral and written form. Present at group meetings, project team meetings and company-wide meetings

Requirements:

  • Senior level: Advanced Degree in Engineering, Biochemistry, Immunology, or similar fields with 2+ years of cell therapy manufacturing and/or process development experience OR Bachelor’s Degree with 5+ years of cell therapy manufacturing and/or process development experience.
  • Principal level: Advanced Degree in Engineering, Biochemistry, Immunology, or similar fields with 5+ years of cell therapy manufacturing and/or process development experience OR Bachelor’s Degree with 8+ years of cell therapy manufacturing and/or process development experience.
  • Expertise in clinical scale cell immunotherapy manufacturing or process development (i.e. human immune cell isolation, T cell activation, gene transfer, and cell culture expansion).
  • Experience with cell immunotherapy analytical testing, including phenotyping, ddPCR, VCN, vector identification, mycoplasma, viability, etc.
  • Understanding of protein upstream and downstream bioprocessing.
  • Working knowledge of GMP, ISO, DOE, and QBD principles. Familiar with FDA requirements.
  • Proficiency with at least some of the various cell therapy bioprocessing systems: G-REX, Prodigy, Wave-mixed Bioreactor, Cell Counter, Flow Cytometry, MACS, Metabolite Analyzer, ddPCR, VCN and vector identification, etc.
  • Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment.
  • Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

#LI-KW1

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary:

Our Process Development team is looking for a talented & driven upstream research associate to play a key role in the development and execution of upstream processes for Synthekine’s various drug candidates. The successful candidate will show an aptitude and affinity for working with upstream scientists towards developing robust fermentation and/or cell culture processes for transfer to manufacturing facilities.

Key responsibilities include supporting production of recombinant protein and/or antibody expression in mammalian host systems in bench top scale and bioreactors. You will support cell culture process scale-up to support early and late-stage projects. This position reports to the Director, Process Development.

Key Responsibilities:

  • Maintain mammalian and/or fermentation cell cultures/fermentations in shake flask experiments and/or bioreactor experiments
  • Working with upstream development scientists to effectively execute experiments with a goal to increase product expression, process characterization, and process robustness
  • Media formulation, bioreactor building and breakdowns, sampling and sample analysis
  • Monitoring and troubleshooting of shake flask and/or bioreactor experiments
  • Working with upstream development scientists on any tasks that may be assigned relating to upstream process development
  • Robust documentation in electronic laboratory notebook system
  • Review of reports related to upstream process development
  • Data review and presentation may be required
  • Develop an experimental plan and be able to execute cell culture and/or fermentation studies in laboratory
  • Perform routine laboratory operations such as seed culture expansion in shake flasks and bioreactors, production cultures in shake flasks, wave bag and single use bioreactors, product harvest, routine in-process analytical testing, etc.
  • Support process optimization and process characterization work to develop scalable and manufacturing friendly processes
  • Some nights and weekends may be required for sampling, inoculation, troubleshooting

Requirements:

  • BS in Biology, Biochemistry or Chemical/Biochemical engineering or in a related life-sciences field
  • Minimum 5 years of experience in cell culture/fermentation process development and/or manufacturing sciences supporting cell culture operation in the biopharmaceutical/biotechnology industry.
  • 3 years of hands-on experience in process scale-up or operation of large-scale bioreactors and cell culture equipment desired
  • Excellent aseptic technique a must
  • Ability to think critically, analytically and to have strong troubleshooting and problem-solving skills based on deductive reasoning.
  • Self-motivated with the ability to work independently and collaboratively in cross functional teams
  • Excellent interpersonal, verbal and written communication skills
  • Proven ability to manage ambiguity and thrive in startup environments to build and establish new facilities, teams, and processes
  • Ability to work with a sense of urgency in a fast-paced environment

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

Apply here.

Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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