(Associate) Director, CMC Analytical Development

Lead and oversee external analytical development within the CMC organization for gene therapy programs.

Manage analytical activities performed at CDMOs and external testing laboratories, ensuring timelines, quality, and scientific standards are achieved.

Provide scientific oversight for analytical method development, qualification, validation, transfer, and troubleshooting activities.

Support analytical strategies for drug substance and drug product development from early clinical stages through late-phase development.

Create and approve Certificate and Analysis for sponsor owned Drug Substance, Drug Product, and Starting Materials.

Author, review and approve analytical protocols, reports, specifications, method validation packages, and stability data generated by external partners.

Drive analytical readiness for regulatory submissions including IND, IMPD, BLA, and MAA filings.

Collaborate closely with Manufacturing, Quality, Regulatory Affairs, and external partners to ensure alignment of CMC objectives.

Support analytical investigations, deviations, OOS/OOT assessments, comparability studies, and change controls.

Contribute to selection, onboarding, governance, and performance management of CDMOs and analytical service providers.

Ensure all outsourced analytical activities comply with GMP and applicable regulatory expectations.

Act as the internal analytical SME for modalities including AAV, DNA, RNA and LNPs

Advanced degree in Analytical Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmaceutical Sciences, or related field (MS/PhD preferred).

At least 10 years of direct hands-on experience with gene therapy product development is required.

Experience managing outsourced analytical activities through CDMOs and external laboratories.