Associate Director, Analytical Development & Quality Control

About the role

The Associate Director, Analytical Development & Quality Control will lead QC activities supporting clinical-stage radiopharmaceutical development programs. This role will serve as the primary QC representative across development programs, managing technical relationships with external CDMOs, contract laboratories, and suppliers.

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.
• Maintain oversight of external partner performance, identify risks, and drive timely resolution of technical, quality, and operational issues.

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.

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

Qualifications

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.

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

Skills

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

Benefits

Competitive and comprehensive benefits package including a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement.

Generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region.

Reasonable accommodations for qualified applicants and employees.

Foster a diverse and inclusive workplace.

Equal opportunity employer.