Associate Scientist / Senior Associate Scientist, LNP Process Science

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 110 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 highly driven hands-on (Senior) Associate Scientist to conduct manufacturing and process development operations for drug product formulations using lipid nanoparticle platforms. The successful candidate will contribute to the continual improvement of our drug product platform, supporting 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 be an integral part of a cross functional team optimizing novel approaches for delivery for our gene therapy platform.

RESPONSIBILITIES:

• Design and execute experiments to optimize the drug product formulation process using both nucleotides and lipid nanoparticles (LNPs).

• Support the production and characterization of LNP formulations targeted for research and pre-clinical programs.

• Collaborate with cross-functional departments to aid in the development and evaluation of LNP formulations for product delivery.

• Understand processes to enable representative LNP production at all scales.

• Maintain thorough electronic lab notebooks and ensure completion of all appropriate protocols and documentation.

• Communicate findings internally and present results broadly in cross-functional meetings.

QUALIFICATIONS:

• Minimum of B.S. with a minimum of 2 years experience or an M.S. degree in Chemical Engineering, Pharmaceutics, Materials Science, Polymer Chemistry, Chemistry, Biochemistry, or related field.

• Experience in drug product formulation and process development of nanoparticles. Specific experience with lipid nanoparticles is preferred.

• Familiarity with process engineering principles and Design of Experiment (DOE) statistical tools.

• Demonstrated ability to operate in a fast-paced environment.

• Excellent communication, collaboration, interpersonal and organizational skills.

• 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 (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.