Radiopharmaceutical Development Lead, CMC

Bristol Myers Squibb; Indianapolis (IN); In loco; USD 124.000 - 151.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible Time Off

11 paid company holidays

Paid vacation

Descrizione del lavoro

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Senior Manager, Radiopharmaceutical Development/CMC in Indianapolis. You will lead end-to-end radiopharmaceutical process development, scale-up, and tech transfer, coordinating across discovery, regulatory, and quality teams to drive clinical and commercial programs.

You will design experiments, enable IND-enabling studies, author regulatory documents, and mentor junior scientists while traveling up to 20% to support

Competenze

• Requires Ph.D./M.S./B.S. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with industry experience.
• 8+ years in drug development, manufacturing, CMC or related fields in pharma, preferably radiopharmaceuticals.
• Demonstrated experience in radiopharmaceutical formulation and process development and GMP manufacturing.
• Proven track record leading IND-enabling studies and supporting regulatory submissions (IND/NDA).
• Experience with technology transfer from preclinical to clinical manufacturing.
• Working knowledge of GMP regulations (FDA/EMA/ICH) and NRC requirements.
• Experience in hot cell environments and with automated synthesis platforms is highly desirable.

Mansioni

• Provide scientific and technical leadership across RayzeBio's drug product development platform.
• Lead design and execution of experiments for scale-up and automation of radiopharmaceutical processes.
• Drive technology transfer from preclinical to clinical manufacturing stages.
• Collaborate with Engineering and Operations to define specifications and equipment needs.
• Investigate deviations with root-cause analysis and implement corrective actions.
• Prepare technical reports and regulatory filings (CMC sections for IND/NDA).
• Collaborate with Regulatory, Quality, Supply Chain, Clinical, and R&D teams.
• Mentor junior scientists and support commercialization activities.
• Travel up to 20% as required.

Conoscenze

GMP knowledge

Regulatory knowledge (FDA/EMA/ICH)

Project management

Technical writing

radionuclide experience

AI-assisted decision making

Formazione

Ph.D./M.S./B.S. in Chemistry/Engineering/Pharmaceutical Sciences

8+ years drug development experience

IND-enabling studies experience

GMP/Regulatory submission exposure

Technology transfer experience

Hot cell/automated synthesis exposure

Descrizione del lavoro

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a Senior Manager, Radiopharmaceutical Development/CMC in Indianapolis. You will lead end-to-end radiopharmaceutical process development, scale-up, and tech transfer, coordinating across discovery, regulatory, and quality teams to drive clinical and commercial programs.

You will design experiments, enable IND-enabling studies, author regulatory documents, and mentor junior scientists while traveling up to 20% to support