Associate Director, QC Analytical Methods

Role Summary

The Associate Director, QC Analytical Methods will oversee the availability of analytical methods needed for release and stability testing of AAV-based products across clinical and commercial development. Responsibilities include managing the analytical method panel, coordinating with CLOs/CDMOs for testing services, and leading technical transfer and phase-appropriate validation to ensure method performance. This hybrid position is based in Lexington, MA, with onsite requirements of at least 3 days per week.

Responsibilities

• Oversee the panel of analytical methods available for release and stability testing, per program.
• Oversee/select appropriate CLOs/CDMOs providing testing services; maintain communication with selected CLOs/CDMOs; perform technical visits or support audits as needed.
• Oversee analytical method SOPs and performance (trending); provide technical input into method performance investigations and troubleshooting.
• Oversee technical transfer needs and contribute to transfer protocols and reports; oversee phase-appropriate validation and validation reports.

Qualifications

• 8+ years of analytical and/or quality control experience in a Biotech or Pharmaceutical industry under GMP environment.
• Strong experience with analytical methods related to cell & gene therapy products, preferably viral vectors, especially AAV.
• Strong experience working with CLOs/CDMOs, outsourcing and communication around the analytical method panel, method performance & troubleshooting, technical transfer, and (phase-appropriate) validations.
• Strong knowledge in QC principles, concepts, industry practices, and standards, including extensive knowledge of cGMP regulations and guidelines.
• Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.).
• Excellent communication, both written and verbal, and interpersonal skills; capable of working independently with minimal supervision and collaborating across teams.
• Strong attention to detail and results-driven in line with project and team objectives.

Education

• Advanced degree (PhD, MSc) in Life Sciences, or equivalent experience.

Additional Requirements

• Hybrid position; office located in Lexington, MA, onsite at least 3 days per week.
• Some travel may be required to visit CLOs/CDMOs (US, Europe) or to the uniQure site in Amsterdam.