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 nonclinical 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: Jake.tookey@discoverinternational.com
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