Associate Director/Director, Biologics and Gene Therapy Process Development and Manufacturing
Watertown, MA — Full-Time
Selecta Biosciences is seeking a highly skilled, collaborative, and motivated candidate to lead our Biologics and Gene Therapy Process Development and Manufacturing Team! This position will be part of our team that is developing protein therapeutics and gene therapies that our combined with our nano-particle ImmTOR technology platform, in pre-clinical, early and late stage clinical development, to address clinically unmet needs.
In this role you will have the opportunity to lead all process development, scale-up, and manufacturing efforts for our protein and gene therapy programs. In this highly visible role within the company, you will partner with both internal groups as well as external CDMOs as you develop our biologics manufacturing strategies.
Principal Duties and Responsibilities
- Lead all process development, scale-up, and external manufacturing efforts for our biologics and gene therapy programs including cell line development, upstream and downstream development, and manufacturing with our CDMO partners.
- In partnership with our CDMOs, design manufacturing processes that are efficient, scalable, and are compliant with global regulatory requirements.
- Lead CDMO selection process. Foster collaborative, high performing relationships with our CDMOs.
- Responsible for developing and executing the group’s technical strategy. Manage group activities including timelines, budget, and goals.
- Represent the Biologics function cross functionally. Serve as biologics/gene therapy drug substance SME in cross-functional teams to support product development, core research and development studies.
- Make technical and strategic contributions to cross functional project teams to ensure successful advancement of development programs.
- Remain current with regulatory trends so that the company’s manufacturing processes are compliant with FDA, EMA and global regulatory requirements.
- Author and review CMC sections of regulatory filings.
Educational and/or Experience
- A Ph.D./MS/BS in biotechnology, cell biology, biochemistry, chemical engineering or related discipline with a minimum of 10+ years of relevant biotech/pharmaceutical industry experience is required. Demonstrated leadership experience and subject matter expertise in biologics or gene therapy process development and manufacturing.
- Technical expertise in one or more of the following areas cell line development, bioreactor development, purification development, gene therapy or biologics manufacturing, process characterization and validation.
- Experience in a GMP regulated environment and/or understanding of regulatory/quality requirements for manufacturing under GMP conditions.
- Knowledge of quality systems and FDA/EU regulations as they relate to process / product development and manufacturing of biologics.
- Ability to travel domestically and internationally to vendor and partner sites as needed to support product development activities.
- Excellent critical thinking and strong technical development skills.
- Excellent verbal and written communication directed to all organizational levels including internal working teams, senior management and external partners and suppliers. Demonstrated ability to work cross functionally.
- Experience in CMC regulatory requirements and authoring CMC sections in support of INDs, BLAs.
- Proficiency in a fast-paced environment, with the ability to successfully navigate through ambiguity and a wide variety of technologies associated with the various therapeutic modalities we are pursuing.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses.
With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
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