CMC Project Manager
Barrington James · Lyon, Auvergne-Rhône-Alpes, France
- On site
- Full-time
- $95,000 / year
- Lyon, Auvergne-Rhône-Alpes, France
Job highlights
- Lead CMC project lifecycle from development to commercial.
- Coordinate cross-functional teams and external partners.
- Manage project plans, timelines, budgets, and risks.
- Support regulatory submissions and manufacturing activities.
- Work on innovative therapies in a fast-paced environment.
About the role
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
Key skills/competency
- CMC Project Management
- Drug Development
- Regulatory Affairs
- GMP Compliance
- Project Planning
- Risk Management
- Stakeholder Management
- CDMO Management
- Tech Transfer
- Process Development
Skills & topics
- CMC Project Manager
- Project Management
- Life Sciences
- Pharma
- Biotech
- CDMO
- Drug Development
- Regulatory Affairs
- GMP
- Manufacturing
How to get hired
- Tailor your resume: Highlight your CMC project management experience, drug development knowledge, and regulatory submission support.
- Showcase your skills: Emphasize your ability to manage cross-functional teams, CDMOs, and multiple projects in fast-paced settings.
- Demonstrate regulatory understanding: Detail your experience with GMP, IND, IMPD, NDA/BLA submissions.
- Prepare for interviews: Be ready to discuss specific examples of project successes, risk mitigation, and stakeholder management.
Technical preparation
Master CMC processes for drug substance and product.,Understand GMP and global regulatory requirements.,Familiarize with regulatory submission types.,Practice project planning and risk mitigation.
Behavioral questions
Describe leading cross-functional project teams.,How do you manage project risks and issues?,Share an experience managing external partners (CDMOs).,How do you ensure regulatory alignment in projects?
Frequently asked questions
- What is the primary focus of the CMC Project Manager role at Barrington James?
- The primary focus of the CMC Project Manager role at Barrington James is to lead and coordinate all Chemistry, Manufacturing, and Controls (CMC) activities throughout the product lifecycle, ensuring timely delivery, regulatory compliance, and successful progression from development to commercial readiness.
- What experience is crucial for a CMC Project Manager candidate at Barrington James?
- Crucial experience for a CMC Project Manager candidate includes proven experience in CMC project management within pharmaceutical, biotech, or CDMO settings, a strong understanding of drug development processes (drug substance and/or drug product), and knowledge of GMP and regulatory requirements.
- How does Barrington James support career progression for this role?
- Barrington James offers clear opportunities for career progression for the CMC Project Manager, fostering a collaborative, science-driven environment where employees can grow and advance their careers within the life sciences sector.
- What kind of regulatory submissions would a CMC Project Manager support at Barrington James?
- A CMC Project Manager at Barrington James would support regulatory submissions such as IND (Investigational New Drug), IMPD (Investigational Medicinal Product Dossier), and NDA/BLA (New Drug Application/Biologics License Application) from a CMC perspective.
- What is the work environment like for a CMC Project Manager at Barrington James?
- The work environment at Barrington James is described as collaborative and science-driven, offering a high level of ownership and visibility across impactful projects, making it an attractive place for professionals in the life sciences.