Senior Manager, Analytical Development & Quality Control

Your Impact

Alpha-9 Oncology is seeking a highly motivated Senior Manager, Analytical Development & Quality Control, to provide technical and operational leadership for quality control and analytical lifecycle activities across clinical-stage radiopharmaceutical programs. This role will serve as a primary analytical and QC representative supporting development programs through data trending, statistical analysis, batch release support, investigation management, CDMO oversight, analytical readiness activities, and clinical supply support.

The successful candidate will lead interactions with multiple external manufacturing and testing partners to ensure effective analytical control strategies, successful technology transfers, timely issue resolution, and reliable clinical supply support. The role will partner closely with Quality, Regulatory, Technical Operations, and Program Leadership teams to proactively identify analytical risks and support program progression. This role is based in our Boston office.

This role is based in our Boston office.

How You'll Contribute

• 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.
• Partner with Quality Assurance and CDMO partners to drive the resolution of deviations, non-conformances, OOS/OOT investigations, CAPAs, and other quality events.
• Review and provide technical oversight for analytical development, method qualification/validation, reference standard programs, stability studies, and technology transfer activities conducted by external partners.
• Collect, organize, trend, and interpret analytical, manufacturing, and stability data to identify variability, emerging risks, and opportunities for process improvement.
• Utilize JMP, Excel, and other statistical tools to evaluate assay performance, process performance, and product quality trends.
• Support analytical method lifecycle management, including method transfer, qualification, validation, and continuous improvement activities.
• Manage the review and approval of analytical and process qualification, validation, and stability protocols and reports, collaborating with CDMOs and internal stakeholders to ensure phase-appropriate development, control strategies, and regulatory readiness.
• Provide technical oversight and support for critical raw material, precursor, API, and drug product development activities conducted by external partners.
• Author, review, and approve technical reports, specifications, protocols, trend reports, and other CMC documentation.
• Collaborate with cross-functional teams and external partners to support clinical supply readiness, analytical control strategies, reference standard programs, and technology transfer activities.

The Skills You Bring

• Ph.D. in Analytical Chemistry, Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related scientific discipline with 6+ years of relevant industry experience, or M.S. with 8+ years of relevant industry experience.
• Strong background in analytical development, quality control, and GMP pharmaceutical development.
• Experience supporting external CDMOs, contract testing laboratories, and technology transfer activities.
• Demonstrated ability to interpret analytical, manufacturing, and quality data to inform technical decision-making.
• Solid understanding of analytical method qualification, validation, transfer, and lifecycle management.
• Experience with statistical analysis and data trending tools (e.g., JMP, Excel).
• Working knowledge of cGMP, ICH, and pharmaceutical regulatory requirements.
• Strong communication, organizational, and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced development environment.
• Ability to travel up to 25% (domestic and international).
  
  

What's in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.