Associate Director, CMC – Analytical Development
About The Position
The Associate Director, CMC – Analytical Development provides strategic and technical leadership for analytical activities supporting the development and commercialization of ²¹²Pb-based APIs and radiopharmaceutical products. Working closely with Process Development, Technical Development, MSAT, Quality, Regulatory Affairs, Engineering, Operations, and external manufacturing partners, the role establishes phase-appropriate analytical strategies, specifications, and control approaches for GMP manufacturing, product release, stability programs, and regulatory submissions. The position leads analytical method development, qualification, validation, transfer, troubleshooting, and laboratory readiness activities to provide robust analytical support for clinical and commercial manufacturing. It also leads CMC regulatory authoring and documentation relating to analytical development and validation, reference standards, and stability programs, and supports global regulatory submissions, lifecycle management, and health authority inquiries. The role provides analytical expertise for CDMO activities and manufacturing investigations, helps align internal development with external manufacturing, and drives continuous improvement to strengthen analytical capability, product and process understanding, and the radiopharmaceutical portfolio. The Associate Director mentors and develops Analytical Development staff and performs other tasks as requested by the VP, CMC and Supply Chain.
Requirements
- M.Sc. in analytical chemistry, pharmaceutical sciences, or a related discipline.
- At least 3 years of experience in the radiopharmaceutical industry, focused on analytical and CMC development.
- Advanced understanding of (radio)pharmaceutical analytical methods and validation, as well as quality control testing.
- Strong understanding of GMP requirements, (radio)pharmaceutical regulations, and industry standards across product development and commercialization.
- Excellent communication, technical writing, and analytical problem-solving skills.
- Demonstrated ability to build, mentor, and lead high-performing CMC teams.
- Ability to manage multiple priorities, meet timelines, and perform effectively in a fast-paced environment.
- Commitment to fostering a collaborative, inclusive, and diverse workplace culture.
Nice To Haves
- Experience in alpha spectrometry.
- Experience in GMP manufacture of radiopharmaceuticals.
- Sound understanding of regulatory requirements and guidelines governing GMP manufacture of radiopharmaceuticals and quality control, such as cGMP, PIC/S, and ICH.
Responsibilities
- Develop phase-appropriate analytical CMC strategies and ensure supporting analytical data, technical documentation, and regulatory submission packages are generated.
- Lead development of analytical control strategies, including analytical methods and drug substance and drug product release and stability specifications.
- Partner with Technical Development, MSAT, and CDMOs on method development, qualification, validation, transfer, and troubleshooting to ensure methods are suitable for GMP manufacturing, release, and stability testing.
- Ensure analytical development activities comply with GMP requirements and applicable radiopharmaceutical regulatory standards.
- Provide technical leadership for regulatory interactions concerning analytical methods, specifications, control strategies, and comparability assessments.
- Partner with Quality Assurance on investigations, change controls, and audit readiness activities.
- Provide targeted analytical support to Precursor Development and External Manufacturing for CDMO-related activities.
- Lead analytical investigations, troubleshoot manufacturing and development challenges, and drive continuous improvement initiatives.
- Mentor, coach, and develop Analytical Development staff.
- Observe company workplace, health and safety, and regulatory policies and procedures.
- Communicate and coordinate with other AdvanCell business unit staff to support seamless and effective activities.
- Adhere to the company’s quality management system processes and policies.
- Perform other tasks as requested by the VP, CMC and Supply Chain.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
