Job description
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 165 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.
Delve further. Please visit www.generationbio.com or follow @generationbio. To see additional roles, please also check out https://generationbio.com/careers/
SUMMARY
Generation Bio seeks a highly motivated Process Engineer I/II to join the Manufacturing, Science and Technology (MS&T) team. The Process Engineer I/II will be responsible for the initial and subsequent CMC programs in process scale-up, documenting the process control strategy, tech transfer and close communication with related CMOs. The focus will be upstream pilot-scale manufacturing of drug substance and on ensuring a robust, scalable, and efficient manufacturing process to produce LNP-based DNA gene therapy drug products for pre-clinical and clinical phase.
The ideal candidate must be comfortable with early phase IND programs, working in a fast-paced environment and familiar with using a risk-based approach to process characterization. Prior experience with small-scale bioreactors (<50L) and experience in a GMP environment is required. The candidate should also have a thorough understanding of root cause investigations, technical report writing, change control and requirements of the CMC modules for an IND.
RESPONSIBILITIES:
- Upstream scale-up, development, and process characterization of drug substance.
- Identify key vendors for raw materials and identify critical material quality requirements.
- Support the launch of the upcoming Generation Bio space that will include equipment and process qualification for clinical manufacturing.
- Partner with internal peer groups within Product and Process Research (PPR), Upstream Process Development (UPS), Downstream Process Development (DSP), Analytical Development (AD) and Quality to build CMC strategies and tactics.
- Work closely with the USP/DSP groups to establish key scale-related and manufacturing development strategies, including critical quality attributes (CQAs) to produce the drug substance, which include key process parameters or ranges, in-process control strategy and release testing.
- Work closely with the AD group to establish sampling and testing programs to achieve CQAs.
- Support cross-functional technology transfer projects with a goal of developing the regulatory strategy for manufacturing operations.
- Prepare, analyze, and present data internally to cross functional team.
- Prepare and review process flow diagrams, development reports, and SOPs/batch records.
- Responsibility for relevant CMC source documents necessary for regulatory filings or health authority interactions.
- Supports process characterization projects and completes all required documentation, ex. research reports, characterization summaries, etc.
- Identify opportunities to improve systems and practices, and drive harmonization across manufacturing platform.
- Communicate approaches and results to senior management in the CMC, Quality, Pre-Clinical and Research and Development groups.
QUALIFICATIONS:
- BS. or M.S. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent.
- A minimum of 2 years of industry experience preferred
- Use of small-scale Bioreactors and use aseptic technique.
- Experience in development and scale-up of a gene therapy or related processes.
- Experience in regulated environments (e.g. GMP manufacturing).
- Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes.
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 (to include traits historically associated with race including, but not limited to, hair texture, hair type, hair length, and protective hairstyles such as braids, locks, twists, hair coverings, and Bantu knots), 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.
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