Director, Early Development CMC

curium • Maryland Heights, MO

9d

About The Position

The Director, Early Development CMC will provide strategic regulatory and technical leadership for Chemistry, Manufacturing, and Controls (CMC) activities supporting early-stage biologic and radioligand therapeutic and diagnostic programs. This individual will partner closely with cross-functional CMC teams responsible for advancing novel oncology candidates from preclinical development through First-in-Human (FIH) and early clinical proof-of-concept studies through BLA / NDA filing.
The role requires experience in biologics development or small molecule development drug product formulation, analytical development, and regulatory CMC requirements. The Director will serve as the Regulatory CMC representative on multidisciplinary program teams and ensure development activities support aggressive clinical timelines while maintaining compliance with global regulatory expectations.

Requirements

• PhD, MS, or BS in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biology, Chemistry, or related discipline.
• 10–15 years of pharmaceutical or biotechnology industry experience.
• Significant CMC development experience supporting biologics and small molecule development.
• Experience advancing products from discovery through Phase 1/2 clinical development.
• Experience filing BLA.
• Experience authoring regulatory CMC documentation.

Nice To Haves

• Advanced degree preferred.
• Antibody-based therapeutics.
• ADCs or targeted biologics.
• Oncology drug development.

Responsibilities

• Develop and execute integrated CMC development strategies supporting early clinical programs through registration.
• Define CMC regulatory milestones aligned with overall program objectives.
• Establish phase-appropriate manufacturing and control strategies.
• Provide inputs to technical risk assessments and mitigation plans.
• Provide strategic leadership and lead the preparation of key regulatory documents including IMPD/ Module 3 sections.
• Support interactions with FDA, EMA, MHRA, and other global regulatory agencies.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree