CMC Project Manager

We’re partnering with an innovative and fast-growing organisation within the life sciences sector looking to appoint a CMC Project Manager. This is a fantastic opportunity to play a key role in driving the development and delivery of complex products across the full CMC lifecycle.

You’ll work cross-functionally with technical, regulatory, and manufacturing teams, ensuring projects are delivered on time, within scope, and aligned with global regulatory expectations.

The Role

As a CMC Project Manager, you will lead and coordinate CMC activities across development programmes, acting as the central point of contact between internal teams and external partners.

You’ll be responsible for ensuring seamless progression from early development through to commercial readiness, with a strong focus on timelines, risk management, and regulatory alignment.

Key Responsibilities

• Lead CMC project planning and execution across drug substance and drug product activities
• Coordinate cross-functional teams including process development, analytical, manufacturing, QA, and regulatory
• Develop and manage detailed project plans, timelines, and budgets
• Identify and mitigate project risks, ensuring proactive issue resolution
• Drive communication between internal stakeholders and external CDMOs and partners
• Support regulatory submissions (IND, IMPD, NDA/BLA) from a CMC perspective
• Oversee tech transfer, scale-up, and manufacturing activities
• Ensure all CMC activities align with GMP and global regulatory requirements
• Provide regular project updates to senior leadership and stakeholders

What We’re Looking For

• Proven experience in CMC project management within pharma, biotech, or CDMO environments
• Strong understanding of drug development processes across CMC (drug substance and/or drug product)
• Experience working with cross-functional technical teams
• Knowledge of GMP and regulatory requirements
• Experience supporting regulatory submissions is highly desirable
• Strong organisational, communication, and stakeholder management skills
• Ability to manage multiple projects in a fast-paced environment

Why Consider This Role?

• Opportunity to work on innovative and impactful therapies
• High level of ownership and visibility across projects
• Collaborative, science-driven environment
• Clear opportunities for career progression