CMC Expert M/F (CDI)

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Sur place; EUR 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Shareholding

Health insurance

Holidays & RTT

Transport support

Résumé du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is seeking a senior CMC Expert for our Toulouse site (Oncopole). You will lead chemistry development, optimize synthesis routes, and support technology transfer for new drug candidates, collaborating with cross-functional teams.

Ideal candidates have a chemical engineering degree or PhD in chemistry, 10+ years in CMC, and fluent English. Teleworking up to 2 days per week is possible under company rules.

Qualifications

• Chemical engineer or PhD in chemistry with minimum 10 years' CMC experience across multiple clinical studies.
• Fluent English essential and extensive experience in cGMP.
• Experience managing a CDMO and leadership of chemistry development programs is required.
• Regulatory experience drafting INDs/IMPDs/NDAs/MAAs and related questions.

Responsabilités

• Propose a pharmaceutical strategy aligned with CMC expertise and ensure it is transcribed into dossiers.
• Sign QOS and variations requiring signed CMC expertise.
• Provide chemical, analytical and CMC support for development programs.
• Define and manage the chemistry budget across all development phases.
• Represent CMC to authorities and draft CMC sections of regulatory submissions.

Connaissances

CMC expertise

English fluency

Project leadership

Formation

PhD in Chemistry

Chemical Engineering

Outils

cGMP

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:

• 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 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...

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.

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-Derma, 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.