Associate Director, CMC

Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that deliver powerful alpha‑emitting payloads directly to tumors. Our pipeline spans multiple first‑in‑class programs—backed by a GMP‑compliant, state‑of‑the‑art radiopharmaceutical facility in Hamilton, we’re turning cutting‑edge science into real‑world impact for patients. Join us at the forefront of radiopharma innovation and be part of turning breakthrough science into meaningful outcomes for patients—come build what’s next with us!

The Role

This role leads end-to-end execution of AstraZeneca’s manufacturing strategy for radiopharmaceutical conjugates, owning CDMO selection and management for process development, optimization, tech transfer, and cGMP manufacturing of precursor materials from preclinical through commercialization, in full compliance with cGMP, ICH, and FDA expectations. The leader proactively identifies process gaps and CMC risks, partners with global teams to implement mitigation plans and continuous improvements, and guides development, qualification/validation, and transfer of analytical methods and specifications for targeting moieties to ensure robust release, stability, and in‑process control strategies. Acting as the technical subject matter expert with Health Authorities, they contribute to CMC authoring and responses, enable inspection readiness, and drive on-time, in-full delivery of clinical and commercial supply while meeting quality, cost, and timeline objectives across a global, matrixed environment

Responsibilities

• Drive execution of the manufacturing strategy for AstraZeneca’s pipeline of radiopharmaceutical conjugates.
• Identify, select, and manage Contract Development & Manufacturing Organizations (CDMOs) for process development, optimization, and cGMP manufacturing of radiopharmaceutical conjugate precursors to support clinical programs and commercial supply, ensuring compliance with cGMP, ICH, and FDA regulations.
• Oversee process development and manufacturing activities from preclinical stages through commercialization.
• Proactively identify process gaps and risks, collaborating with the global AZ team to develop and implement mitigation plans.
• Support the development of analytical methods and specifications required for process research and development of targeting moieties.
• Serve as a technical subject matter expert in interactions with regulatory agencies regarding precursor development and manufacturing.

Qualifications

• Education: Master’s or Ph.D. in Chemistry, Chemical Engineering, or a related field.
• Minimum of 5 years in process development and manufacturing within the biotech or pharmaceutical industry.
• Demonstrated success in developing phase-appropriate API manufacturing processes with strong expertise in organic synthesis, process efficiency, and safety.
• Proven ability to manage U.S. and international CRO/CDMOs for cGMP API manufacturing, ensuring timely delivery of project milestones.
• Solid understanding of regulatory compliance requirements (FDA, GMP, EHS).
• Strong interpersonal and communication skills for effective collaboration in cross-functional teams.
• Highly meticulous, self-motivated, decisive, and capable of thriving in a fast-paced, start-up environment.
• Hands-on experience with process scale-up and technology transfer.
• Preferred: Experience in solid-phase peptide synthesis and bioconjugation.

At AstraZeneca, we foster a collaborative, innovative culture with opportunities to work across teams, functions, and geographies.   You’ll join a collaborative, innovative community with opportunities to work across teams, functions, and geographies—where your ideas move fast and your impact is visible. We’re committed to sustainability and equity, taking bold action on climate, access to healthcare, and disease prevention.

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Join us to push the boundaries of science and deliver life‑changing medicines. Apply now and take the first step towards a fulfilling career at Fusion, an AstraZeneca company.

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Annual base salary for this position ranges from 131,201.60 to 172,202.10.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.