CMC Expert MF (CDI)

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 CMC Expert on a permanent contract for our Toulouse site (Oncopole 31) reporting to Pierre Fabre Medical Cares R&D Department.

You will be responsible for the development and manufacturing of new drug candidates. This includes selection and optimization of small molecule synthesis routes manufacturing support scale-up process and technology transfer of the active characterization of RSM and impurities validation of development activities for validation definition of specifications and validation of processes.

Your role within a pioneering company in full expansion:

More specifically you will:

- Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a CMC expert. Carry out CMC quality reviews (module 3) of product and project dossiers as an in-house expert and provide chemical expertise as part of Due Diligences.

- You sign QOS and variations requiring signed CMC expertise (1.4.1).

- Analyze and appraise product issues relating to analytics and assess the work required to resolve them.

- Provide chemical expertise (analytical and CMC) for all requests as well as technological and CMC watch. You are responsible for the CMC Work Package for new projects in cross-functional collaboration with clinical non-clinical research regulatory quality and other departments.

- You will be responsible for monitoring work in line with this strategy in terms of quality/cost/timeframe with internal departments and subcontractors and will provide expert support and scientific guidance to CMC subcontractors.

- Represent Pierre Fabres CMC expertise to the authorities in case of questions. You draft and/or check the CMC parts of INDs/IMPDs/NDAs/MAAs including questions and answers to the authorities.

- Define and manage the chemistry budget for all development phases

- Support as chemistry expert internal life cycle management programs and regulatory changes for assets and raw materials (i.e. nitrosamines report assessment ethylene glycol and diethylene glycol assessment regulatory changes...).

This position is compatible with teleworking up to 2 days a week according 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:

Chemical engineer or PhD in chemistry

Minimum 10 years experience in CMC expertise 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 managed a CDMO

Experience of technical leadership in chemistry and 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.