Director, Analytical Sciences

Voyager Therapeutics - Lexington, MA

- Senior

Lexington, MA

Chemical Manufacturing

About the position

The Director, Analytical Sciences will be a leader within the group with a strong background and expertise in analytical development and process analytics. Primary responsibilities will include leading the team in development and qualification of analytical assays, technical analysis and investigations to support process development activities for Voyager pipeline programs and partner programs. The ability to independently design experiments, analyze data and report the results concisely as well as taking the initiative to successfully drive Voyager's projects and manufacturing process are all important aspects of the position.

Responsibilities

• Provide strong leadership and manage a team of scientists in analytical development - be responsible for setting of goals, execution of work, training, development and mentoring of colleagues.
• Follow budgetary considerations.
• Lead innovation, development and optimization of the analytical development processes including process analytics and method development.
• Lead/Develop protocols and associated execution for analytical science & bioassays method development to support of the manufacture of Voyager pipeline and partner programs.
• Generate, manage, and maintain critical methods and data in a highly organized manner including experimental reports, SOPs, batch records, technology transfer documents, etc.
• Act as the SME to maintain various external relationships with partners, vendors and CMOs/CROs for Analytical Science Development.
• Support and lead the transfer of developed analytical protocols and analytical processes to internal and external manufacturing partners.
• Lead/support process analytical activities associated with characterization, PPQ and authoring of relevant regulatory documents.
• Contribute to the execution of CMC projects through development of timelines, strategy and tools/workflows that can enable more streamlined execution.
• Mentor colleagues.
• Contribute to scientific documentation of patent applications and subsequent internal and external presentation and/or publication of new technologies.

Requirements

• MS or PhD in Biochemistry/Biology/Chemistry/Virology/ Chemical Engineering or a related field
• 13+ years (with MS) or 10+ years (with PhD) of relevant experience in industry - Protein therapeutics, gene therapy or viral vector assay experience in leading an analytical sciences group
• Broad understanding of global expectations of Health Authorities (FDA, EMA, MHRA) in Pharmaceutical/Analytical Development and GxP regulations.
• Previous experience with good documentation practices. Significant attention to detail and accuracy in writing and following protocols.

Nice-to-haves

• Direct knowledge of a broad range of analytical methods (HPLC, ELISA, Mass Spec. etc.) through prior significant hands-on experience with a deep understanding of the methods.
• Experience with AAV ddPCR and potency assays is a plus.