Associate Director, Analytical Development & Quality Control

Your Impact

Alpha-9 Oncology is seeking a highly experienced and motivated Associate Director, Analytical Development & QC to join our growing organization. Our team is looking for a scientific leader to guide and execute the development, validation, and implementation of quality control procedures to support our clinical-stage programs.

As a highly visible and impactful role in our early-stage company, this position requires a high degree of collaboration, multi-tasking ability, and a desire to thrive in a fast-paced environment. The ideal candidate will be a self-starter with a passion for mentorship and a strong background in analytical sciences. This role is based in our Boston office.

How You'll Contribute

• Serve as a scientific leader for the CMC analytical activities as they relate to the testing of diagnostic and therapeutic radiopharmaceutical drug products and critical raw materials (peptide and small molecules).
• Manage the technical relationship with external CDMO partners from initial project proposal through test method validation and clinical supply. Drive the on-time completion of deliverables.
• Provide scientific guidance on analytical method development and validation to drive program progression. Review and interpret experimental data from internal teams and external partners.
• Collaborate and guide laboratory-based scientists, ensuring efficient execution of development programs and successful tech transfer.
• Drive authorship, review, and approval of key technical documents, including SOPs, specifications, and protocols.
• Collaborate with Quality Assurance to ensure compliance and to support the management of quality events (non-conformances, investigations, deviations, CAPAs).
• Author CMC documents for IND and CTA regulatory submissions, ensuring the accuracy and integrity of all analytical data.
• Partner with cross-functional teams (Project Management, R&D/Discovery, Quality Assurance, and Regulatory) to achieve program goals and timelines.
• Proactively identify resource constraints, develop mitigation strategies, and establish contingency plans to avoid program delays.

The Skills You Bring

• Ph.D. in Analytical Chemistry, Radiochemistry, Pharmaceutical Sciences, or a related field, with at least 8 year of industry experience (postdoctoral experience may be included); or an MS with at least 11 years of relevant experience.
• Demonstrated hands-on experience with analytical method development specific to radiopharmaceuticals, peptide, or small molecules (HPLC, radio-HPLC, MS, and gamma counting).
• Prior experience managing CDMOs is required, specifically hand-on experience leading analytical tech transfer, validation and QC testing in a cGMP environment.
• In-depth knowledge of cGMP, ICH, and other global regulatory guidelines.
• Experience with authoring and/or contributing to CMC sections of regulatory submissions is a plus.
• Knowledge or experience with QC testing of radiopharmaceuticals is preferred.
• Strong oral and written communication skills, and a talent for cross-functional collaboration.
• 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.

Company Summary

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.

More about Alpha-9 Oncology

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.