CMC Project Manager MF CDD- HF

We are Pierre Fabre Laboratories a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey.
Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène Ducray A-Derma Klorane René Furterer and Pierre Fabre Oral Care.
By joining us you become part of a meaningful company where the human dimension is essential. You become a participant in the We Care Movement a movement that values excellence and innovation within passionate teams. Together we push the boundaries of science to unite health and beauty for the benefit of all because Every time we care for a single person we make the whole world better.

Present in 120 countries with a team of over 10000 employees we are proud to create a scientific and human impact today and tomorrow! If caring is at the heart of your values join Pierre Fabre Laboratories and become a key player in the We Care Movement.

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 Cares 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...

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.-

At Pierre Fabre Laboratories we believe that our greatest asset is our people.

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 companys 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.