CMC Project Manager M/F -CDD- H/F

Your mission

We are recruiting a Projet Manager for CMC (CMC-PM) on a short-term contract (12 months) for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Medical Care's R&D Department.

You will be responsible for supporting the CMC expert team for the clinical projects with Pierre Fabre as lead CMC.

This includes the coordination all along the pharmaceutical development from phase 1 to registration of new biological or chemical drug candidates, and transversal subjects assigned to this team.

Your role within a pioneering company in full expansion:

More specifically, you will:

- Coordinate CMC subteam activities with respect of timelines

- Be responsible for internal CMC team meetings organization and with partners

- Support CMC subteam in the planification of the CMC activities and for budget management (Focal point of P&O department (Outsourcing Manager, Planner, Portfolio manager)

- Support CMC Subteam Leader (Pharma Strategic Leader or PSL) in his tasks

- Support Governance meetings preparation/coordination of slides-deck completion for CMC

- Coordinate preparation and update of CMC documentation for clinical submissions, such as:

• IND / IMPD initial CMC sections
• Amendments and updates for formulation/process changes, scale-up, site changes
• Module 3 draft planning ahead of Phase 3 / registration

- Be the point of contact for expert team transversal subjects as CMC-PM

You will report to the Head of Pharmaceutical development on this role

This position is compatible with teleworking up to 2 days a week according to company rules.

We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation...

Who you are ?

Your skills at the service of innovative projects:

MSc or Engineer in pharmaceutical science (chemistry, biologic, formulation or analytics)

Minimum 5 years' experience in conducting pharmaceutical development plan for CMC acquired through several clinical studies (phase 1 to phase 3), ideally up to registration.

Fluent English essential

Extensive experience in Good Manufacturing Practices (cGMP)

You have already managed a CDMO or Partner

Experience of technical leadership in project management associated with development programs is required.-

We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.