Join our generation.
Associate Director / Director, Drug Product Formulation
Cambridge, Massachusetts, United States
Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including titration to effect and the ability to re-dose. Our unique GeneWave technology allows us to overcome the limitations of existing and emerging approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time. Our vision is to make our therapies available at or near birth to maximize their lifetime impact, allowing people to live full lives unaffected by genetic disease.
We are a community of creative problem-solvers and independent thinkers. We are guided by strong personal integrity, humility, and energized by the collaborative, learning mindset required to create solutions for patients and their families.
Generation Bio seeks an energetic and highly motivated Director/Associate Director to guide Drug Product formulation activities at both the internal laboratories as well as external vendor-performed contracts. Specifically, drug product will consist of a DNA gene vector and will be delivered in a lipid nanoparticle (LNPs). The successful candidate should have experience in LNPs delivery and their manufacturing processes and they will work closely with scientists in the Process and Analytical Development departments.
- Directing all development work for the manufacturing processes for Drug Product formulation using both DNA vectors and Lipid Nanoparticles (LNPs).
- Managing a staff of scientists engaged in the lipid formulation activities as well as manufacturing of drug product for non-clinical/animal studies.
- Work closely with the Analytical Development scientist to establish sampling and testing programs for the Drug Product.
- Overseeing all technology transfer projects for both internally and externally delivery of the drug product manufacturing.
- Supervising efforts of external vendors working on drug product formulations.
- Being responsible for the compliance of these efforts with Generation Bio and regulatory standards.
- Communicating approaches and results to senior management in the Research and Development groups.
- Partnering with peer groups within Upstream and Downstream Process Development and Analytical Development to build CMC strategies for our clinical candidates.
- Ph.D. in Biochemistry, or equivalent
- Minimum of 8-10 years relevant experience.
- Experience in regulated environments (e.g. Quality Control) highly desired, with experience in a GMP setting helpful.
- Ability to achieve consensus across internal stakeholders in Development, Quality, and Research.
- Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged
- Ability to diversify technical skillsets in a fast-paced organization
- Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes
POSITION: Full-Time, Exempt
EEOC Statement: Generation Bio believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.