Director, CMC: Precursor Development & Manufacturing

AdvanCell; Boston (MA); Vor Ort; USD 170.000 - 230.000; Vollzeit

Zusammenfassung

AdvanCell seeks a Director of CMC – Precursor Development & Manufacturing to lead the development, optimization, and GMP manufacturing of precursor molecules and reference standards for radiopharmaceuticals.

Role requires extensive CMC experience, leadership across chemistry and analytical teams, and collaboration with external CDMOs to ensure regulatory readiness and timely delivery for clinical and commercial programs.

Qualifikationen

• Ph.D. in Chemistry (organic or process chemistry) required.
• 6+ years in CMC, process development, or related operations.
• Expert in synthetic chemistry and impurity control.
• GMP manufacturing and regulatory experience.
• Experience selecting/managing CDMOs and external partners.
• Strong leadership and cross-functional collaboration skills.

Aufgaben

• 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 to ensure GMP readiness and fit-for-use methods.
• Ensure GMP-compliant manufacturing of precursor materials at CDMOs.
• Support tech transfer and scale-up for clinical and commercial manufacturing.
• Align CMC activities with ICH guidelines and regulatory requirements.
• Prepare/review CMC documents for regulatory submissions (IND/CTA/MAA).
• Collaborate with QA on deviations, investigations, and change controls.
• Drive continuous improvement in process efficiency and cost of goods.
• Mentor CMC staff and foster a strong technical culture.

Kenntnisse

PhD in Chemistry

CMC leadership

Process development

GMP manufacturing

CDMO management

Analytical development

Regulatory writing

ICH guidelines

Multi-step synthesis

Problem solving

Ausbildung

PhD in Chemistry

Tools

HPLC

LC-MS

Jobbeschreibung

AdvanCell seeks a Director of CMC – Precursor Development & Manufacturing to lead the development, optimization, and GMP manufacturing of precursor molecules and reference standards for radiopharmaceuticals.

Role requires extensive CMC experience, leadership across chemistry and analytical teams, and collaboration with external CDMOs to ensure regulatory readiness and timely delivery for clinical and commercial programs.