Alpha9oncology
Associate Director, Analytical Development & Quality Control
Boston, Massachusetts, United States · Director
Sponsorship not specifiedDetected 1 day ago
API DevelopmentProduct ManagementSupply ChainRecruitingClinical TrialsGMPLeadershipCommunication
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- This role is based in our Boston office.
- While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
- Company Summary Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors.
Responsibilities
- 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.
- 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.
Requirements
- At least 5 years of experience managing external CDMOs, contract testing laboratories, and/or GMP manufacturing operations.
- Strong understanding of analytical method qualification, validation, transfer, and lifecycle management.
Compensation
- Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement.
Benefits
- 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.
- With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
Equal opportunity
- Equal Opportunity Employer.
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