Your mission
Job Summary:
We are seeking a CMC Project Leader with a strong background in small molecule chemistry and development, who combines technical knowledge with regulatory insight and a hands-on, communicative approach. This position is key in driving CMC strategy and execution across development phases — from preclinical to clinical — ensuring alignment with quality standards and global regulatory expectations.
You will coordinate cross-functional CMC efforts including chemistry, formulation, analytical, and manufacturing development, and act as a central interface with regulatory affairs and external partners (CDMOs) with a deep understanding of GxP regulations. Experience in preparing for and supporting CMC regulatory submissions and audits is essential.
Responsibilities:
We are seeking a CMC Project Leader with a strong background in small molecule chemistry and development, who combines technical knowledge with regulatory insight and a hands-on, communicative approach. This position is key in driving CMC strategy and execution across development phases — from preclinical to clinical — ensuring alignment with quality standards and global regulatory expectations.
You will coordinate cross-functional CMC efforts including chemistry, formulation, analytical, and manufacturing development, and act as a central interface with regulatory affairs and external partners (CDMOs) with a deep understanding of GxP regulations. Experience in preparing for and supporting CMC regulatory submissions and audits is essential.
Responsibilities:
- Lead CMC activities across drug substance (DS) and drug product (DP) development and IMP production for small molecules.
- Coordinate e.g. DS related activities and DP formulation development including analytical method development, process development, and tech transfer to manufacturing partners.
- Represent CMC in cross-functional project teams and ensure seamless collaboration across internal and external stakeholders.
- Drive the preparation and review of CMC sections of regulatory dossiers (e.g., IMPDs, INDs, amendments).
- Independently draft and write CMC sections of regulatory dossiers (e.g., IMPDs, INDs), ensuring quality and compliance.
- Ensure compliance with ICH guidelines, GxP, and other relevant regulatory requirements.
- Support and/or lead CMC audits (regulatory inspections and partner audits), including audit readiness activities and deviation / CAPA management.
- Maintain oversight of CMC activities such as timelines, budgets, risks, and deliverables.
- Facilitate communication and decision-making across CMC sub-functions and leadership teams.
- Support operational oversight of IMP activities during clinical trials in collaboration with Clinical Operations, including label management, temperature excursions, randomization processes, and document review.