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Director, Viral Vector Sciences

FULL TIME EXEMPT
HOME OFFICE: SOUTH SAN FRANCISCO, CA
REQ: 108

CERo Therapeutics, Inc., is a privately held biopharmaceutical company pioneering cell-based therapies that incorporate multiple forms of tumor clearance into single cells. The company’s core technology platform engineers T cells to express immune receptors called chimeric engulfment receptors (CERs) that enable T cells to target, induce cellular damage, uptake tumor antigen, and remove tumor cells. This approach effectively unites the anti-tumor attributes of both innate and adaptive immune responses into a single T cell product. Our vision is a new class of cell-based medicines with the potential for more complete and durable anti-tumor responses, while maintaining a favorable toxicity profile across multiple cancer indications.

We are seeking a highly motivated Director, Viral Vector Sciences. This role will support CERo’s Research, Process Development, Quality, Regulatory and Clinical Research organizations. Responsibilities include overseeing strategy, design and implementation of processes for the manufacture of lentiviral vectors for stable delivery of synthetic DNA into human T cells. This individual will support strategy, knowledge base, and core deliverables related to lentiviral platform development, processes, and characterization that are required to meet corporate IND and CMC milestones. The ideal candidate will have a consistent record in lentiviral vector construction, characterization, CMC strategy and support management of contract manufacturing organizations (CMOs). This is a key role that will serve as a point of contact for vector development, process, and characterization strategy, for internal and external programs across functions (Research, Process Development, Quality, Regulatory, Clinical Research). The individual will also be leading characterization strategy for in-process testing, and safety testing of cell banks and lentiviral vector used for CERo’s clinical development programs.

REQUIRED SKILLSET:

  • Assist with optimization and further development of lentiviral vector platform and quality control strategy within a cross-functional team to support multiple cell therapy programs and pipeline activities
  • Manage the day to day research activities of the R & D vector core laboratory
  • Support the management team by providing technical leadership within the organization on lentiviral vector biology, construction, process development and manufacturing
  • Assist with oversight of vector transfers to CMOs
  • Generate internal technical documents, SOPs and presentations for cross-functional communication
  • Drafting, reviewing, approving, and supporting regulatory filings, including IND amendments, BLAs, and regulatory responses
  • Assist in the development of SOPs, justification of specifications, quality control, and sampling plans in support of cell line banking and lentiviral vector stocks
  • Develop and lead strong collaborative relationships with internal and external collaborators
  • Develop and mentor a group of diverse scientists and research associates to enable cross-functional collaboration, career development, and leading innovation

Education and Preferred Skillset

  • Preferred BA/BS: 15 years or MA/MS: 13 years or PhD: 10 years post graduate work
  • (PhD in Virology, Molecular Biology or equivalent with 7+ years of proven experience in applied virology including lentiviral vector development)
  • Proficient in ICH, FDA, EMA, and JP regulations and guidance
  • Expertise in USP, EP, JP, etc. regulations for suitability of methods applied to viral vector screening and characterization methods
  • Demonstrated experience with development and optimization of lentiviral vector bioreactor processes
  • Experience writing CMC sections for IND/ BLA
  • Experience with viral risk assessments, viral safety testing and control strategies
  • Understanding of cGMP requirements
  • Possess the ability to present technical information to both technical and non-technical audiences

CERO RECRUITING

CERo’s compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other benefits and perks such as: health, dental, vision, life and disability insurance benefits, commuter benefits and 401K match!

CERo is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request an accommodation.

CERo Human Resources leads recruitment and employment for CERo. Unsolicited resumes sent to CERo from recruiters do not constitute any type of relationship between the recruiter and/or recruiting agency and CERo and do not obligate CERo to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

To apply: please reach out to: cero@cero.bio

CERo Therapeutics is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or age, and CERo? will not tolerate discrimination or harassment based on any of the above characteristics.

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