Senior/Principal Scientist (Process Development)

Voyager Therapeutics

Voyager Therapeutics

Lexington, MA, USA
Posted on Saturday, April 15, 2023

About Voyager

Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging innovative expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis and Neurocrine Biosciences as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes preclinical programs in Parkinson’s disease, Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), each with validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com

Job Summary:

Voyager is seeking a highly motivated Senior Scientist to join the TechOps organization to lead the Downstream process development group.

Primary responsibilities include managing the downstream process development team and planning/executing development activities for the manufacture of pre-clinical and cGMP grade rAAV products. This role will participate in, and lead internal AAV production campaigns, author appropriate technical documents, carry out technology transfer to CDMOs, as well as participate in person in plant activities for cGMP manufacturing campaigns. The ability to independently organize and design experiments, analyze data and report the results of their own and the team’s work in a concise and well documented manner, as well as take the initiative to successfully drive Voyager’s projects and manufacturing process are all important aspects of the position.

This role provides leadership and guidance to less experienced downstream process development scientists conducting process development experiments, with direct hands-on support . This is a lab-based position in Lexington, MA.

Key Responsibilities:

  • Lead the downstream team, providing guidance on experimental design, execution and data analysis
  • Develop protocols for AAV vector purification using column chromatography and other downstream processing technologies.
  • Plan and schedule Process Development activities within each respective program and liaise with other functions to meet established timelines.
  • Develop departmental goals and drive towards improving core purification technology capabilities.
  • Establish team objectives and action plans to effectively meet departmental goals.
  • Lead evaluation and technical development to improve the platform process as well as troubleshoot various unit operations.
  • Oversee and provide hands-on support for day to day operations in the Downstream Purification lab
  • Train and mentor team members on procedures, operations, and new technologies
  • Prepare appropriate technical documents to define purification process unit operations, author technical reports, draft batch records etc. to support technical transfer of developed processes to external CDMOs.
  • Contribute to CMC development strategy and IND/BLA writing and review
  • Represent DSP team in cross functional team meetings.

Specialized Knowledge and Skills:

  • Previous experience working with the downstream production of protein biologics, vaccines, rAAV viral vectors in mammalian or insect production systems.
  • Previous experience working with AKTA Chromatography systems and software.
  • Previous experience packing and qualifying chromatography columns.
  • Previous experience working with multiple filtration modes - Depth Filtration, Tangential Flow Filtration and Nanofiltration.
  • Previous experience managing viral clearance studies at an external CRO is desired.
  • Previous experience with ultracentrifugation is desired.
  • Hands-on experience working with an analytical team analyzing and characterizing biopharmaceutical products using methods such as SEC, Light Scattering etc.
  • Strong desire to learn new techniques and willingness to work as part of a larger team.
  • Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents.
  • Ability to be highly productive in a fast-paced and teamwork-oriented environment.
  • Effective written and verbal communication skills
  • Strong organizational and time management skills
  • Previous supervisory experience

Requirements:

  • A minimum of a bachelor’s degree in Pharmaceutical Sciences, biochemistry, chemistry, chemical engineering, biotechnology, or related field

Experience:

  • BS in relevant scientific discipline with 13+ years relevant experience, MS in relevant scientific discipline with 12+ years relevant experience, Ph.D. (or equivalent) in relevant scientific discipline, with 5+ years of industry or relevant experience.