Director / Senior Director, Technical Operations
Outpace Bio is a drug development company reimagining cell function through protein design to make cells the future of medicine. We believe that cells are naturally programmed by evolution to make the wrong decisions in cancer and autoimmune disease, and curative cell therapies will only be achieved by overcoming the default biological mechanisms that limit their efficacy and safety. Led by co-founders of Lyell Immunopharma, our world-class scientific team is developing smart cell therapies that reprogram complex biological processes in ways that small molecules and biologics cannot. We use protein design and synthetic biology to engineer cells to make better decisions inside the patient and to productively engage the endogenous immune system. Our unique partnership model allows us to efficiently explore diverse cell therapy modalities and accelerates clinical validation so that we can bring curative therapies to patients. We value passion for science, innovation, collaboration, inclusion, and respect.
At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to building an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.
Outpace Bio is seeking a Director/Senior Director, Technical Operations to lead Process and Assay Development, Quality Control and to identify CDMO partners for GMP production of lentiviral vectors and autologous CAR T cells. This position will report directly to the CSO and will be responsible for our manufacturing strategy and overseeing and managing the technical aspects of our CAR T cell therapy programs. The Tech Ops Head will work closely with R&D functional groups (Platform, Immunology, CAR T development), and will be an integral part of the R&D leadership team working in close collaboration with other scientific and business leaders at Outpace. Key responsibilities will include developing internal processes and assays for CAR T production at scale, tech transfer to CDMOs and CROs, oversight of CDMO production, and providing necessary CMC technical support for IND submissions.
Responsibilities (position responsibilities may include, but are not limited to):
- Lead the development and optimization of Outpace’s CAR T manufacturing processes, including lentivirus and CAR T production
- Develop and implement standard operating procedures (SOPs) for the production of CAR T cells
- Collaborate with Immunology, CAR T Pipeline Development and other research functions to establish CAR T characterization and functional assays that may be used for product release
- Identify, evaluate and onboard key CapEx equipment to support internal PD research and development for Outpace CAR T programs
- Identify key CDMO and CRO partners to facilitate GMP CAR T production for clinical trials
- Lead tech transfer activities from Outpace to CDMO partnersEnsure compliance with regulatory requirements and industry standards for cell therapy manufacturing
- Lead CMC sections for IND submissions, including writing technical documentation and interacting with regulatory agencies when required
- Representing the company in external meetings and collaborations with partners
- Participate as a member of the Functional Leadership group to help develop and guide research and development strategy across departments
- Stay current with the latest technologies and methodologies in the field of CAR-T cell therapy and process development, and contribute to the generation of new hypotheses and ideas to drive the PD research forward
- Mentor and provide career development for a team of scientists
- PhD in Immunology, Bioengineering, Chemical Engineering or related discipline with 5+ years of postdoctoral research experience, preferably in an biotech or pharmaceutical setting
- Strong experience in cell therapy process development, specifically with CAR T cells
- Experience in the biotech or pharmaceutical industry, with a proven track record of successfully developing and/or commercializing cell-based therapies
- Deep subject matter expertise with state-of-the art cell manufacturing equipment to support cell isolation and processing, closed system cell culture using bioreactors or other devices and fill-and-finish and cryopreservation for storage and transportation
- Strong experience in cGMP (Current Good Manufacturing Practice) production of cell-based therapies
- Experience in leading and managing a team of scientists and technicians in a process development and manufacturing setting
- Strong knowledge of cell culture, aseptic techniques, and cell biology
- Experience with scale-up and manufacturing of cell therapies, including experience with CDMOs and other GMP-compliant facilities
- Familiarity with regulatory requirements and industry standards for cell therapy manufacturing
- Strong problem-solving and analytical skills
- Strong communication and collaboration skills, including the ability to effectively present information to both scientific and non-scientific audiences
$185,000 - $250,000 a year
Individual compensation is dependent upon current market data, individual experience, and pay parity within Outpace Bio. This position is a Director level position with a compensation range of $185,000 - $220,000 for a Director role and $220,000 - $250,000 for a Senior Director role.
Full Time Employees (and their eligible dependents) may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and twelve paid holidays throughout the calendar year. Outpace also offers a generous paid parental leave policy to all regular full-time employees.
Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
To protect the safety of our employees, Outpace Bio requires all new hires to submit proof of full vaccination (per CDC guidelines) from the COVID-19 virus before commencing employment. If you are unable to receive a COVID-19 vaccine due to a serious medical condition or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation. An accommodation request must be submitted at the time an offer is extended.