Head of Upstream Process Development (Sr Scientist/Assoc Director/Director)
4D Molecular Therapeutics, located in Emeryville is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions. We are seeking a talented and motivated Head of Upstream PD (Sr Scientist-Director level, depending on experience) to join our team in developing upstream (cell culture) processes for viral gene therapies.
Responsibilities include but not limited to:
- Manages and mentors a team of Associates and Scientists on upstream development, scale-up, production, and process characterization.
- Manages and mentors Associates on process development, optimization, characterization, and transfer projects, providing scientific expertise, guidance, and development opportunities
- Determines 4DMT Upstream priorities/strategies and guides the development process from flatware through bioreactors
- Demonstrates innovative design, development and execution of process development projects through literature review and scientific teamwork.
- Leverages strong understanding of mammalian cell culture, scale up, and bioreactor design, and specific challenges of gene therapy vector production to design, assess and interpret experimental data, using DOE and statistical techniques.
- Develops robust, scaleable, transferable processes for upstream production of clinical viral gene therapy material. Leads process transfer to CMOs and supports regulatory filings.
- Leads both from the bench (hands-on laboratory work) and from the desk (designing studies, analyzing data, preparing reports and documents)
- Writes study reports, process characterization reports, transfer documents, and regulatory documents. Authors manuscripts and presents results at appropriate scientific meetings
- Contributes to building a culture that embraces continuous learning, improvement and innovation, and encourages team members to expand their technical skill base and deepen their gene therapy expertise. Maintains a current awareness and contributes to current scientific literature; actively applies new concepts and technologies as appropriate
- Leads and supports research initiatives such as new technology development and continuous improvement projects
- Observes and complies with Company’s Safety policies and procedures
- PhD (Chemical engineering, Bioengineering, Biology, Biochemistry, Virology, or related field) with 2+ years experience, MS with 5+ years experience, or BS with 10+ years experience in process development of large molecule or cellular therapies.
- Knowledge of viral gene therapy (adeno associated viral vectors preferred); background in protein and/or viral engineering
- Knowledge and working experience with cell culture process development in mammalian cells, including adherent and suspension cells, media development, process scale-up, bioreactor design and optimization, and transfection.
- Experience with process characterization and transfer is essential. Expertise in DOE and statistical analysis of data is highly desirable, as is experience in deviation management and root cause analysis.
- Experience leading teams of Research Associates
- Successful demonstrated ability to work independently and lead others in designing and developing experiments, analyzing and interpreting data in a rigorous way
- Ability to multi-task and support more than one project simultaneously
- Ability to work in a team based environment, cooperatively and supportive of multiple viewpoints and approaches
- Understanding and knowledge of key scientific software programs
- Understanding and knowledge of regulatory requirements for biologic products
- Strong organizational skills, analytical and problem solving skills
- Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one on one discussions, team meetings and partnership interactions
Qualified candidates may submit a resume and cover letter to firstname.lastname@example.org.
4D Molecular Therapeutics offers competitive benefit and compensation plans as well an entrepreneurial, collaborative and collegial work environment.