Director, Radiopharmaceutical Process Development & GMP

AdvanCell; Boston (MA); On-site; USD 180,000 - 235,000; Full time

Job summary

AdvanCell seeks a Director of Radiopharmaceutical Process Development to shape phase-appropriate CMC strategies and oversee scale-up of 212Pb-based APIs and radiopharmaceutical products.

You will lead process development, characterization, technology transfer, and manufacturing readiness for GMP-compliant production while coordinating with cross-functional teams including Technical Development, MSAT, Quality, Engineering and Operations.

Qualifications

• Ph.D. in chemistry, engineering, pharmaceutical sciences or a relevant discipline.
• Minimum 4 years of radiopharmaceutical industry experience with CMC development and process development.
• Strong GMP knowledge and radiopharmaceutical regulatory understanding.
• Excellent communication, technical writing and analytical problem-solving skills.
• Demonstrated ability to mentor and lead high-performing CMC teams.

Responsibilities

• Develop phase-appropriate CMC strategies and generate supporting data, documentation, and regulatory packages.
• Collaborate with Technical Development and MSAT to align process development, optimization, and scale-up for 212Pb APIs.
• Drive process characterization and lifecycle studies to establish CPPs, CQAs, and control strategies.
• Establish phase-appropriate drug substance/product specifications based on data and strategy.
• Ensure GMP compliance and regulatory standards in process development.

Skills

Leadership

Regulatory writing

Analytical problem-solving

Communication

Project management

Education

Ph.D. in chemistry or related field

Job description

AdvanCell seeks a Director of Radiopharmaceutical Process Development to shape phase-appropriate CMC strategies and oversee scale-up of 212Pb-based APIs and radiopharmaceutical products.

You will lead process development, characterization, technology transfer, and manufacturing readiness for GMP-compliant production while coordinating with cross-functional teams including Technical Development, MSAT, Quality, Engineering and Operations.