Senior Fermentations Scientist

GreenLight Biosciences is seeking an exceptional and highly motivated process scientist to help advance its RNA platform technology for plant and animal health products. The successful candidate will support R&D initiatives by leading the development of scalable processes for RNA production. A strong technical background in fermentation process development is required, and experience with late-stage biotech process development is preferred. Essential qualities include strong leadership, effective communication, creative problem-solving, project management expertise and adaptability. This role will require a solution-orientated mentality with a hands-on approach which means working directly with the engineers, operators, etc in the plants at CMOs and suppliers.

MAJOR RESPONSIBILITIES

· Serve as the primary liaison between Process Development teams, production teams in our Rochester-based pilot plant and commercial-scale production facility, as well as Contract Development and Manufacturing Organizations (CDMOs).

· Lead the development and scale-up of GreenLight Bio’s fermentation technology, including fermentation processes for the production of RNA starting materials and enzymes.

· Guide internal teams in evaluating process robustness via process characterization and development of in-process control strategies.

· Facilitate risk assessments (process, facility, equipment, method, and materials) and drive mitigation strategies in collaboration with Manufacturing, Quality, PD, Supply Chain, and others

· Independently design and execute fermentation production experiments, analyze data, and collaborate with team members to integrate results into process designs and project plans.

· Lead process scale-up and tech transfer activities to pilot plant and commercial manufacturing sites across the network and develop and maintain comprehensive tech

transfer documentation (process descriptions, risk assessments, process flow diagrams, bill of materials, process summaries etc.).

· Author and review technical reports to support regulatory filings.

· Collaborate with cross-functional project teams, including Manufacturing, Quality, Regulatory, Supply Chain.

· Maintain diligent and organized records.

· Serve as person-in-plant during scale-up, engineering runs, and initial GMP production campaigns to provide on-site technical support and ensure alignment with the transferred process.

· Clearly communicate results and recommendations to colleagues, managers, and senior management, assisting in project decision-making.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

· Ph.D. or MS in fermentation related disciplines with degree in Chemical Engineering, Biochemistry, Molecular Biology, or related discipline with at least 5 years of industry experience, specializing in Fermentation Development.

· Broad knowledge of the overall industrial fermentation, enzyme and plasmid recovery, GMP development and commercialization process.

· Experience in managing process development and process characterization at CDMOs.

· Experience leading fermentation process development and scale up approaches is required. GMP experience and exposure to cell-free production processes is highly desirable.

· Understanding of cGMP, quality-by-design, ICH and other regulatory guidelines as they relate to product development, process characterization, control strategies and commercial manufacturing is expected.

· Experience with process validation is preferred.

· Experience with primary clarification methods is desirable.

· Strong organization, communication, and interpersonal skills are required, with the ability to work both independently and in a collaborative work environment.

Salary: $140,000- $150,000