Associate Director, Analytical Development

Position Summary:
Associate Director of Analytical Development, Technical Operations—analytical subject matter expert responsible for analytical method development, validation, and transfer for drug substances and drug products (cGMP; FDA/ICH/EU standards) generated by external labs/manufacturers.

Responsibilities:
- Independently manage/oversee analytical method development, validation, and transfer at CRO/CMO labs (small molecules).
- Oversee specification setting for drug substance and drug product at CDMOs/CROs.
- Review/approve validation and transfer protocols/reports, SOPs, and experimental reports.
- Manage development activities (IPC, release testing) and research (impurity characterization).
- Provide scientific/technical guidance to internal/external project teams.
- Troubleshoot OOS/OOT root causes; evaluate and provide corrective actions.
- Support submission sections (DS/DP analytical package; structural characterization) and write technical chemistry reports.
- Ensure manufacturing/release compliance with applicable regulations; maintain knowledge of US/EU GMPs, USP, Ph. Eur, and ICH.

Education/Experience:
- B.S. in Chemistry/Biochemistry/Life Sciences (or equivalent).
- 8+ years analytical development/validation/transfer in biotech/pharma; managing external CRO/CMOs; reviewing analytical data.
- Direct knowledge of HPLC, GC, MS, NMR, IR, dissolution.

Additional Skills/Experience:
- Courage, community, patient focus, teamwork; strong communication, organization, decision-making, collaboration, attention to detail.
- Manage multiple priorities; team player; independent and team work.
- Veeva/Quality Doc a plus; travel 15–20%.

Benefits/Compensation (as stated):
- Benefits: premium health, work-life/well-being programs, life insurance, disability, retirement match, generous paid time off.
- Target base pay: $150,000–$195,000.

Application instructions:
- Accepting applications on an ongoing basis until a candidate is selected.