Partnering closely with Process Development, MSAT, Quality, Regulatory Affairs, and External Manufacturing partners, 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.
The role is responsible for establishing phase-appropriate analytical strategies, specifications, and control approaches that support GMP manufacturing, product release, stability programs, and regulatory submissions.
The successful candidate leads CMC regulatory authoring and documentation related to analytical development and validation, reference standards, and stability programs, supporting global regulatory submissions, lifecycle management activities, and responses to health authority inquiries. The role also drives continuous improvement initiatives to strengthen analytical capability, product and process understanding, and the advancement of the company's radiopharmaceutical portfolio.
Working in close collaboration with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership across analytical method development, qualification, validation, transfer, and laboratory readiness activities to ensure robust and reliable analytical support for clinical and commercial manufacturing.
In addition, the Associate Director provides analytical expertise to the Sr. Director of Precursor Development and Director of External Manufacturing to support CDMO activities, manufacturing investigations, and the implementation of effective analytical control strategies. The role helps ensure alignment between internal development programs and external manufacturing operations to maintain a reliable, scalable, and compliant supply network.
Key Responsibilities and Duties
Develop phase-appropriate analytical CMC strategies and ensure generation of the supporting analytical data, technical documentation, and regulatory submission packages
Lead the development of phase-appropriate analytical control strategies, including analytical methods and release and stability specifications for drug substances and drug products, to support product development and regulatory objectives.
Partner with Technical Development, MSAT and CDMOs to support method development, qualification, validation, transfer, and troubleshooting activities, ensuring analytical 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 related to analytical methods, specification, 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 investigation, troubleshoot manufacturing and development challenges, and drive continuous improvement initiatives
Mentor, coach, and develop Analytical Development staff.
Other Responsibilities
Observe the Company’s workplace, health and safety, and regulatory policies and procedures.
Engage and communicate with other AdvanCell business unit staff to ensure that activities are undertaking seamlessly and effectively.
Adhere to the Company’s quality management system processes and policies.
Other tasks as requested by the VP, CMC and Supply Chain
Essential Skills, Qualifications, Industry and Educational Requirements
M.Sc. in analytical chemistry, pharmaceutical sciences or a related discipline.
Minimum 3 years of experience in radiopharmaceutical industry with a focus on analytical and CMC development
Advanced understanding of (radio)pharmaceutical analytical method & 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
Proven 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.
Desirable Skills, Qualifications, Industry and Educational Requirements
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 (e.g. cGMP, PIC/S, ICH).
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