Scientist / Senior Scientist, Drug Product – Manufacturing Sciences And Technology

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 an energetic and motivated Scientist to join the MS&T team within the CMC group. The position will play a key role in process development and manufacturing of our drug product formulations using lipid nanoparticle platforms. The successful candidate will report to the Associate Director, DP-MS&T and will be an integral part of a cross functional team optimizing novel approaches for drug product development of our gene therapy platform. The successful individual would also have the opportunity to assist in managing external studies with CMOs.
Responsibilities

• Works directly with internal groups to establish key manufacturing development strategies such as critical quality attributes, key process parameters and ranges, in-process control strategy, and release testing.
• Designs and performs process development/optimization experiments to scale up production of Drug Product to support pre-clinical and clinical development.
• Oversees and performs hands-on development work for manufacturing processes of Drug Product formulations using Lipid Nanoparticles (LNPs).
• Keeps clear and transferable records of experiments, updates protocols, writes technical reports and data summaries to detail process development work.
• Supports the management of external, technical interfaces to external manufacturing organizations.
• Plans, organizes, and takes ownership of assigned projects and champions new data-driven ideas to contribute to project advancement.
• Manages the day to day materials, equipment, and other resource requirements to maintain Drug Product output.
• Works with other functional groups across the company to coordinate timelines and deliverables, and to stay abreast of overall project goals.
• Compiles data from process characterization projects to prepare appropriate documentation for regulatory submissions.

Qualifications

• Degree in Pharmaceutics, Materials Science, Polymer Chemistry, Chemical Engineering, Chemistry, Biochemistry, or related field.
• Proven ability to effectively plan and organize complex work activities and prioritize task completion to meet schedules and deadlines.
• Strong interpersonal, organizational, and communication skills are required for this role.
• BS. with a minimum of 8 years, or an M.S. with a minimum of 6 years, or Ph.D. with a minimum of 3 years of related experience in the biopharmaceutical industry.
• Demonstrated ability to operate in a highly collaborative and fast-paced environment.
• Technical understanding and experience in biopharmaceutical process manufacturing operations and tech transfer to external organizations.
• Background in nucleic acid-LNP formulation or other nanoparticle technologies is highly desired for this role.
• Proven track record of working effectively with cross functional teams including research and development, pre-clinical, process development, analytical development, and quality.
• Experience and well-developed understanding of process development approaches related to drug product.
• Knowledge of GxP regulations and QbD principles are helpful.

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 (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.