Associate Director, Analytical Development & Quality Control

1 мес. назад

USADirectorOnsite

qcquality controldata reviewinvestigation managementcdmo oversightclinical supply management

Provide technical and operational leadership for quality control activities in clinical-stage radiopharmaceutical programs.

Требования

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)

Другое

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.
 
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.
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.
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. 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.
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.