CMC & Precursor Innovation Director — Scale & Compliance

AdvanCell; Boston (MA); On-site; USD 220,000 - 285,000; Full time

Job summary

AdvanCell is seeking a Sr. Director, CMC - Precursor Development & Manufacturing to lead development, optimization, and GMP manufacturing of precursor molecules and reference standards for radiopharmaceutical products. You will drive process design, impurity control, and regulatory submissions, partnering with CDMOs and QA to ensure timely, compliant substance delivery.

The role requires a Ph.D. in Chemistry and 6+ years in CMC/process development, with strong leadership, cross-functional

Qualifications

• Ph.D. in Chemistry (Organic or Process Chemistry) or related discipline.
• 6+ years in CMC, process development, or technical operations.
• Strong expertise in synthetic chemistry and impurity control.
• GMP manufacturing knowledge and regulatory expectations.
• Experience selecting/managing CDMOs and external partners.
• Excellent problem-solving, communication, and leadership skills.

Responsibilities

• Lead process development, optimization, and scale-up for precursor molecules and reference standards.
• Provide SME in route design, impurity control, and process robustness.
• Guide analytical development with GMP-ready methods for manufacturing, release, and stability.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Project management

Cross-functional collaboration

Problem-solving

Education

Ph.D. in Chemistry (Organic/Process Chemistry)

Tools

HPLC

LC-MS

Analytical method validation

Job description

AdvanCell is seeking a Sr. Director, CMC - Precursor Development & Manufacturing to lead development, optimization, and GMP manufacturing of precursor molecules and reference standards for radiopharmaceutical products. You will drive process design, impurity control, and regulatory submissions, partnering with CDMOs and QA to ensure timely, compliant substance delivery.

The role requires a Ph.D. in Chemistry and 6+ years in CMC/process development, with strong leadership, cross-functional