Chemical Expert CMC -CDI- M/F

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Hybrid; EUR 110,000 - 140,000; Full time

Benefits offered by this job

Incentives

profit-sharing

Pierre Fabre shareholding with match

health and provident insurance

16 days RTT + 25 days personal leave

Job summary

Pierre Fabre Laboratories in Toulouse (Oncopole) seeks a Chemical Expert for CMC on a permanent contract. You will lead DS development, optimize synthesis routes, support scale-up, and manage technology transfer of the active.

The role requires 10+ years in CMC, English fluency, cGMP expertise, and experience with CDMOs; you will collaborate across clinical, regulatory, and quality teams and interact with authorities.

Qualifications

• PhD in chemistry or chemical engineering required.
• Minimum 10 years' CMC experience across several clinical studies (phase 1–3).
• Fluent English required.
• Extensive experience in cGMP.
• Experience managing a CDMO.
• Technical leadership in chemistry and project management for development programs.

Responsibilities

• Propose a pharmaceutical CMC strategy aligned with chemical expertise and document it in dossiers.
• Carry out CMC quality reviews (module 3) of DS and participate in due diligences.
• Analyze and appraise DS chemistry issues and define work to resolve them.
• Provide chemical expertise for internal requests and for CMC watch.
• Own the CMC Work Package for new projects, coordinating across clinical, non-clinical, research, regulatory and quality.
• Monitor work against strategy, ensuring quality, cost and timing.
• Represent Pierre Fabre's CMC chemistry to authorities if needed.
• Draft/check DS module sections for INDs/IMPDs/NDAs/MAAs, including Q&As.
• Define and manage the chemistry budget for development phases.
• Support lifecycle management and regulatory changes for assets and raw materials.

Skills

Chemical engineering

PhD in chemistry

English proficiency

cGMP experience

CDMO management

Project leadership

Education

PhD in Chemistry

Chemical Engineering degree

Job description

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 Chemical Expert for CMC 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 drug substance (DS) 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, development activities to support validation, definition of specifications and process validation. Your role within a pioneering company in full expansion: More specifically, you will:

• Propose a pharmaceutical strategy in line with its chemical expertise and ensure that it is transcribed into dossiers as a CMC expert.


• Carry out CMC quality reviews (module 3) of DS and project dossiers as an in-house chemical expert and provide chemical expertise as part of Due Diligences.


• Analyze and appraise DS issues relating to chemistry, and assess the work required to resolve them.


• Provide chemical expertise 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 OutSourcing Managers (OSM).


• Represent Pierre Fabre's CMC chemistry expertise to the authorities in case of questions.


• You draft and/or check the quality module for DS 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.

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.

About us

Pierre Fabre Laboratories is the world’s second-largest dermo-cosmetics company and one of Europe’s leading pharmaceutical laboratories. Our Dermo-cosmetics & Personal Care portfolio includes international brands such as Eau Thermale Avène, Ducray, Klorane, A-Dema, René Furterer, Même Cosmetics, Darrow and Elgydium. The Medical Care activity covers 5 main therapeutic fields: oncology, dermatology, rare diseases, primary care and family health care. By choosing Pierre Fabre Laboratories, you will join a company where the human dimension is essential, where excellence and innovation are valued, within passionate teams united by common values, committed to pushing 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.