Generation Bio seeks an enthusiastic and highly motivated Scientist to drive development of upstream processes for production of our novel gene therapy product. This position reports to Senior Scientist, Upstream Process Development and joins a team of scientists dedicated to developing upstream processes to support the manufacture of early stage clinical material. The successful candidate will champion the continual improvement of our GMP compliant process to support several clinical drug substance candidates. Candidates with proven upstream process development experience and an ability to adapt to a dynamic environment will be highly valued This role will have high visibility in a company that is expanding to support a dynamic pipeline.
Primary responsibilities for this role include:
- Design and execution of experiments to define operating ranges and process improvements of our critical cell-based process. The process contains essential molecular biology components.
- Experience manipulating and analyzing DNA.
- Support development of the next-generation of our drug substance process by evolving critical processes and identifying key technologies.
- Interfacing with cross-functional teams and tech transfer to CMOs.
- BS, MS, or PhD in Bioengineering, Biotechnology or related discipline
- 6+ years (BS), 4+ years (MS), 0+ years (PhD) of relevant experience in an industrial lab setting
- Proven technical proficiency in upstream process development (e.g. cell line development), viral production development, or DNA vaccines
- Experience with insect cells (Sf9/Sf21) is highly desirable
- Strong collaboration and team-working skills
- Results-driven with excellent attention to details
Desired experience includes:
- Experience establishing key process parameters and controls of upstream processes
- Experience working with and optimizing molecular biology systems
- Technical expertise in developing scalable and GMP compliant upstream processes used to generate biotherapeutics
- Ability to lead upstream tech-transfer activities to CMOs and build strong relationships with collaborating companies
- Proven ability to independently design and prioritize experiments
- Track record of managing multiple projects
- Experience generating and reviewing protocols, reports, and batch records
- Prepare, analyze, and present data internally to cross functional teams