CMC Expert M/F (CDI)

Pierre Fabre Laboratories; Occitanie; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Teleworking up to 2 days/week

Résumé du poste

Pierre Fabre Laboratories seeks a Chemical Engineer or PhD in chemistry to lead CMC strategy across development programs in Toulouse (Oncopole). Fluent English and extensive cGMP expertise are essential as you collaborate with cross-functional teams and external CDMOs.

You will manage CMC work packages, prepare regulatory submissions (INDs/IMPDs/NDAs/MAAs), and mentor teams while controlling budgets and timelines in a fast-growing, innovative environment.

Qualifications

• 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.

Responsabilités

• Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a CMC expert.
• 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 will be responsible for monitoring work in line with this strategy, in terms of quality/cost/timeframe.
• Represent Pierre Fabre’s CMC expertise to the authorities in case of questions. You draft and/or check the CMC parts of INDs/IMPDs/NDAs/MAAs.
• Define and manage the chemistry budget for all development phases.

Connaissances

Fluent English

cGMP

CDMO management

Project management

CMC expertise

Analytical chemistry

Formation

Chemical engineer or PhD in chemistry

Description du poste

Who we are ?

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 10,000 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”.

Your mission

We are recruiting a CMC Expert on a permanent contract for our Toulouse site (Oncopole, 31), reporting to Pierre Fabre Medical Care’s 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 Fabre’s 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 up to company rules.

• 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:

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 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.