Director CMC

Director, CMC (Chemistry, Manufacturing & Controls)

3 days a week onsite (Non-negotiable) and open to relocators from within EU.

Our client is seeking an experienced CMC leader to take ownership of end-to-end CMC strategy and execution across multiple development programs. This role sits at the centre of technical development, ensuring our assets advance smoothly, compliantly, and on time.

Key Responsibilities

• Lead CMC strategy for assigned programs and act as the primary CMC representative on cross‑functional project teams.
• Oversee planning and delivery of CMC activities, including timelines, risk management, technical decisions, and phase‑appropriate readiness.
• Partner closely with analytical, process development, manufacturing, quality, regulatory, and non‑clinical teams to ensure integrated development plans.
• Support interactions with global health authorities, including contributing to regulatory submissions and responses.
• Guide internal teams and external partners (CDMOs, consultants), including contract review, budgeting, and resource planning.
• Provide leadership to CMC sub‑teams, driving progress, alignment, and high‑quality scientific and regulatory outputs.
• Participate in due‑diligence assessments and oversee CMC aspects of in‑licensed or partnered programs.
• Manage multiple projects in a matrix environment while balancing priorities, resources, and timelines.
• Foster a culture of scientific rigor, collaboration, and continuous improvement within the CMC function.
• Stay current with evolving regulatory expectations and industry practices.

What We’re Looking For

• Bachelor’s degree with extensive industry experience, or advanced degree with relevant CMC leadership background.
• Demonstrated experience leading CMC or technical development programs (typically 8+ years at a similar level).
• Strong knowledge of drug development, CMC requirements, and global regulatory expectations.
• Excellent communication skills with the ability to influence and align diverse stakeholders.
• Proven experience working with external partners and managing outsourced development/manufacturing work.
• Strategic mindset with the ability to make sound decisions in dynamic environments.
• Strong leadership, negotiation, and cross‑functional collaboration skills.

Email Applicants:

#CMC #Bigpharma #Biologics

Seniority level

Director

Employment type

Full‑time

Job function

Manufacturing, Research, and Project Management

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing