Scientist - Synthetic DNA Production, Upstream Process
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.
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SUMMARY
Generation Bio seeks an enthusiastic and highly motivated Scientist to join the Production and Process Research (PPR) department within our organization. The PPR group focuses on exploring and developing new, innovative technologies for the continual improvement of our ceDNA production processes for yield gains, scalability, and robustness. This position will drive early-stage development efforts focused on the Rapid Enzymatic Synthesis (RES) based production of ceDNA gene therapy molecules. This role will have high visibility in a company that is expanding to support a dynamic pipeline.
RESPONSIBILITIES:
- Supporting the development of next generation, cell-free ceDNA production efforts through process engineering and identification of key technologies to improve production performance
- Applying engineering principles to characterize and optimize biocatalytic processes
- Optimizing and advancing the enzymatic creation and manipulation of DNA
- Exploring efforts focused on high yielding nucleic acid amplification methods
- Preparing, analyzing, and presenting data internally to cross functional teams
- Completing all appropriate documentation such as protocols, reports, IND enabling documents, etc.
QUALIFICATIONS:
- Degree in Chemical Engineering, Biomolecular Engineering, Biochemistry or equivalent.
- 1+ years (PhD), 5 years (MS), or 7 years (BS) of industry experience; title flexibility possible based on years of experience
- Experience with cell free, bacterial, and/or yeast systems for biomolecule production
- Proven ability to work independently, effectively plan work activities, and prioritize task completion to meet schedules and deadlines
- Strong collaboration and team-working skills
- Deep understanding of enzyme characterization and biochemical reaction optimization
- Sense of urgency, results-driven, and excellent attention to detail
Desired experience:
- Familiarity with multi-enzyme driven bioproduction processes
- Broad understanding of nucleic acid amplification methods and quantitative assays
- Technical expertise in the development of scalable and commercially viable processes in biotech/pharma/food industry
- Experience developing high throughput production pipelines
- Knowledge of cGMP and regulatory guidelines and practices, and how these relate to and impact process development
POSITION: Full-Time, Non-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.