CMC Analytics Director - Radiopharma Development

AdvanCell; Boston (MA); On-site; USD 170,000 - 220,000; Full time

Job summary

AdvanCell is seeking an Associate Director, CMC - Analytical Development to provide strategic leadership for analytical activities supporting 212Pb-based APIs and radiopharmaceutical products.

You will establish phase-appropriate analytical strategies, specifications, and control approaches for GMP manufacturing, release, and stability programs, while leading regulatory writing and submissions and driving continuous improvement.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical problem-solving

Technical writing

Leadership

Cross-functional collaboration

Education

MSc in analytical chemistry or pharmaceutical sciences

Radiopharmaceutical industry experience

Job description

AdvanCell is seeking an Associate Director, CMC - Analytical Development to provide strategic leadership for analytical activities supporting 212Pb-based APIs and radiopharmaceutical products.

You will establish phase-appropriate analytical strategies, specifications, and control approaches for GMP manufacturing, release, and stability programs, while leading regulatory writing and submissions and driving continuous improvement.