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.
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Generation Bio seeks an energetic and highly driven hands-on Scientist to conduct manufacturing and process development operations for drug product formulations using lipid nanoparticle platforms. The successful candidate will champion the continual improvement of our drug product platform to support several clinical drug substance candidates. Candidates with 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 an extensive pipeline.
- Develop scalable and robust processes for the production of lipid nanoparticle (LNP) Drug Product formulations.
- Plan, organize, and take ownership of manufacturing activities required to support research and pre-clinical testing of Drug Product.
- Design and perform process development/optimization experiments to scale up production of Drug Product.
- Supervise, train, and mentor a small team of Associate Scientists.
- Manage the day-to-day materials, equipment, and other resource requirements to maintain Drug Product output.
- Champion new data-driven ideas to contribute to project advancement.
- Author protocols, technical reports and data summaries to detail manufacturing and process development work.
- Work with other functional groups across the company to coordinate timelines and deliverables, and to stay abreast of overall project goals.
- Minimum of Ph.D. or a M.S. with 6 years experience, or a B.S. with 8 years experience in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutics, Materials Science, Polymer Chemistry, or related field.
- Background in nucleic acid formulation is highly desired for this role. Specific background in LNPs or other nanoparticle technologies is a strong plus.
- Strong interpersonal, organizational, and communication skills are required for this role.
- Proven track record of working effectively with cross functional teams including research and development, pre-clinical, manufacturing operations, and quality control.
- Knowledge of GxP regulations and QbD principles are helpful.
- Demonstrated ability to operate in a fast-paced environment.
- Demonstrate a sense of urgency; proactive thinking and multitasking are essential.
- Results-driven with excellent attention to details.
- Proven ability to effectively plan and organize complex work activities and prioritize task completion to meet schedules and deadlines.
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, gender, religion, national origin, gender identity, 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.