Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses its proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA. The platform is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.
We are a thriving, collaborative, creative community of 140 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.
Generation Bio seeks an enthusiastic and highly motivated Scientist to drive development of downstream processes for production of our novel gene therapy product. This position reports to the Lead of Downstream Process Development and joins a team of scientists dedicated to developing downstream 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 downstream 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.
- Develop scalable and commercially viable processes for the purification of our novel genetic medicines.
- Support downstream activities both internally and externally to achieve key development milestones
- Author study plans, protocols, and reports.
- Supervise, train and mentor junior staff.
- Design, prioritize and execute experiments including, operating range studies and process improvements.
- Manage and execute inhouse lab work and studies supporting the development and generation of material for preclinical and clinical testing.
- Support scale up of process steps including filtration (depth filtration, UFDF, sterile filtration), and chromatography (affinity, IEX etc).
- Support downstream tech transfer to CMO and build strong relationships with collaborating companies.
- Prepare, analyze, and present data internally to cross functional teams.
- PhD in Chemical Engineering, Biotechnology or related discipline with minimum 3 years of relevant experience or Master’s Degree with minimum 7 years of relevant experience.
- Proven technical proficiency in downstream process development
- Ability to manage multiple projects and responsibilities simultaneously.
- Strong collaboration and team working skills
- Proven ability to work independently, effectively plan and analyze work activities and prioritize task completion to meet schedules and deadlines.
- Knowledge of cGMP, FDA and USP guidelines practices is a plus.
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.