Director / Senior Director Drug Product Process Development

Generation Bio is a biotechnology company changing what is possible for people living with T cell-driven autoimmune diseases. The company is developing novel therapeutics leveraging its T cell selective cell-targeted lipid nanoparticle (ctLNP) to deliver siRNA in vivo, enabling modulation of T cell activity that causes inflammation and auto-reactive tissue destruction. By selectively modulating T cells that drive disease pathology, ctLNP-siRNA therapeutics could potently block target function with sequence-level specificity while sparing the broader immune system. This potent new modality is designed to reach targets that are poorly drugged by other approaches, opening a broad indication space of T cell driven autoimmune diseases.

We are a thriving, collaborative, creative community of 100 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.

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Summary

Generation Bio seeks an energetic and highly motivated (Sr) Director to join our CMC team and lead the Drug Product Process Development team. This highly visible position will lead a team of scientists and engineers to drive process development and scale-up activities that enable GMP clinical production at external suppliers. The position will work closely with cross-functional colleagues in Research, Drug Product Process Science, Analytical Development, and Quality to deliver on the company objectives.

The successful candidate should have experience in LNP formulations and/or other forms of nanoparticle-based delivery systems as well as leading teams in a fast-paced environment. Additionally, the candidate should have experience with the technical and regulatory requirements to support clinical (GMP) manufacturing and technical transfer to CDMOs.

Responsibilities

• Lead and develop a team of scientists and engineers responsible for translating our platform drug product processes from research to clinical scale
• Work cross-functionally with early research and Drug Product Process Science to transfer, scale, and document manufacturing processes
• Accountable for establishing scalable, controlled, and robust manufacturing processes that support clinical production at external vendors
• Serve as a subject matter expertise to the Technical Operations team and CDMOs for clinical-scale manufacturing activities
• Define key manufacturing development strategies, including critical process parameters and critical quality attributes (CQAs) for the drug product
• Partner closely with the Analytical Development group to establish sampling and testing programs to achieve CQAs
• Establish, review, and approve process flow diagrams, development reports, and batch records.
• Create documents (scale-related development plans and reports, technical memos and protocols, etc.) related to CMC production and testing to support regulatory filings.
• Identify opportunities to improve systems and practices, and drive harmonization across manufacturing platform
  
  

Qualifications

• Ph.D. in Biochemistry, Chemistry, Chemical Engineering, or equivalent with a minimum of 6 years of relevant experience. M.Sc. with a minimum of 12 years relevant experience.
• Broad background in nanoparticle-based delivery systems, experience with LNP process development and technologies
• Knowledge of GxP regulations and QbD principles
• Experience leading and developing a team of scientists and engineers
• Experience supporting external vendors/contract organizations in a GxP setting
• Experience authoring regulatory submissions and responses strongly preferred
• Strong verbal and written communication skills, detail-oriented, exceptionally organized, and possesses the ability to influence change across different stakeholder groups
• Ability to drive decisions and achieve consensus with internal stakeholders including DP Process Science, Technical Operations, Analytical Development, and Quality
• Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged
• Ability to diversify technical skillsets in a fast-paced organization
• Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes
  
  

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.