Associate Director, Analytical Development & Quality Control

Alpha-9 Oncology•Boston, MA

5d•Onsite

About The Position

Alpha-9 Oncology is seeking a highly experienced and motivated Associate Director, Analytical Development & Quality Control, to provide technical and operational leadership for QC activities supporting our clinical-stage radiopharmaceutical programs. This role will serve as the primary QC representative across development programs, leading QC data review and trending, batch release support, investigation management, CDMO oversight, and clinical supply readiness activities. The successful candidate will manage relationships with external manufacturing and testing partners while partnering closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to support API development, CMC activities, and timely execution of clinical supply strategies. This highly collaborative role requires a strong technical foundation, operational mindset, and ability to drive progress across internal and external stakeholders in a fast-paced, growing organization. This role is based in our Boston office.

Requirements

Ph.D. in Analytical Chemistry, Chemistry, Radiochemistry, or a related scientific discipline with at least 8 years of progressive experience in the pharmaceutical or biotechnology industry or M.S with at least 11 years of experience.
At least 5 years of experience managing external CDMOs, contract testing laboratories, and/or GMP manufacturing operations.
Demonstrated success managing multiple external partners and driving technical deliverables across complex development programs.
Experience reviewing and interpreting analytical data to support product quality, investigations, trend analysis, and batch release activities.
Experience leading technical investigations, OOS/OOT assessments, deviations, CAPAs, and non-conformance resolution.
Strong understanding of analytical method qualification, validation, transfer, and lifecycle management.
Knowledge of cGMP, ICH, and global regulatory requirements for pharmaceutical development.
Strong oral and written communication skills with the ability to influence cross-functional and external stakeholders.

Nice To Haves

Ability to travel up to 25% (domestic and international)

Responsibilities

Provide leadership for quality control activities supporting multiple clinical-stage radiopharmaceutical development programs.
Lead QC data review, trending, and lifecycle monitoring to support product quality and program progression.
Manage technical relationships with external CDMOs, contract laboratories, and suppliers to ensure timely execution of testing, investigations, and program deliverables.
Support batch release activities through review of analytical results, investigation assessments, and quality event resolution.
Partner with Quality Assurance and CDMO partners to drive the resolution of deviations, non-conformances, OOS/OOT investigations, CAPAs, and other quality events.
Collaborate with Technical Operations, Regulatory, Supply Chain, and Program Management teams to ensure clinical supply readiness.
Support development and qualification of analytical methods and QC processes as needed throughout the product lifecycle.
Provide technical oversight for critical raw material, precursor, API, and drug product development activities conducted by external partners.
Author, review, and approve technical reports, specifications, protocols, and other CMC documentation.
Monitor external partner performance, identify risks, and drive timely resolution of technical, quality, and operational issues.