Selecta Biosciences
  • Watertown, MA, USA
  • Salary
  • Full Time

Director of Gene Therapy, Manufacturing

NO PHONE CALLS OR AGENCIES PLEASE.

 Background

Selecta Biosciences is seeking a talented and dedicated leader to join our fast paced and growing company!  Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid the immune responses that compromise efficacy and lead to life-threatening complications. Selecta is applying its proprietary Synthetic Vaccine Particles (SVP) to a range of therapeutic areas in which immunogenicity is a key challenge. Our lead program SEL-212 is in phase 2 clinical development for patients with severe forms of gout. Our two fast advancing gene therapy product candidates for inborn errors of metabolism (MMA and OTC) have the unique potential to enable repeat administration, allowing for dose adjustment in patients and maintenance of therapeutic activity over time.

Summary

Selecta's Process Development and Manufacturing group is responsible for producing drug product for use in clinical trials and for scaling production of those drugs for the commercial market.  The Director of Gene Therapy requires a high level of technical expertise in the development and production of adeno-associated viral vectors (AAV), including triple transfection and baculovirus technology. The successful candidate will lead the development and manufacturing of gene therapy products at contract development and manufacturing organizations (CDMOs).

This position requires experience with quality and regulatory requirements related to the cGMP manufacture of gene therapy products. This position involves close collaboration with internal and external analytical, quality, and regulatory groups.  The candidate must be a strong technical leader that is able to make decisions and build a gene therapy department.  Excellent interpersonal and communication skills and the ability to work within a team environment are required.

This position requires excellent ability to multi-task in an extremely fast-paced environment with changing priorities.

Principal Duties/Responsibilities

  • Build a gene therapy department to support the development and manufacturing of gene therapy products
  • Lead the Gene Therapy Chemistry Manufacturing and Control (CMC) Team at Selecta
  • Manage CDMOs performing gene therapy process development and manufacturing activities
  • Travel to CDMO locations as needed to participate in technology transfer and supervise manufacturing activities
  • Ensure robust, scalable, commercially-viable gene therapy manufacturing processes are properly developed
  • Ensure sufficient quantities, quality, and timeliness of deliverables
  • Manage budgets and schedules to meet project/organizational goals
  • Review and approve cGMP-compliant documentation (such as master batch records and SOPs)
  • Performs duties according to applicable Company safety procedures
  • Performs other duties as necessary

Educational and Experience

  • Bachelor's Degree or higher in Biochemical Engineering, Molecular Biology, or related discipline, advanced degree preferred
  • 12 or more years of experience in bioprocess development in the pharmaceutical industry
  • 6 or more years of gene therapy manufacturing experience, including cell culture, purification, and analytical strategies
  • 2 or more years working with CDMOs
  • AAV experience required
  • Travel: Up to 25% of the time, including international travel to CDMO facilities

Work Environment

An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Company policies, rules, and regulations in these as is required.

The Company has active programs on developing novel immunotherapies for various food and environmental allergies.  An employee may be required to work with and/or be exposed to allergens in the laboratory.

 

Selecta Biosciences
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