Formulation Expert M/F - CDI

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Incentives

Profit-sharing

Pierre Fabre shareholding with

Health and provident insurance

16 days of holidays (RTT) in addition

Public transport participation

Very attractive CE…

Résumé du poste

Pierre Fabre Laboratories in Toulouse is seeking a highly experienced Formulation Expert to lead CMC strategy and oversee drug product formulation for development programs, including scale-up and tech transfer.

The role requires 10+ years in CMC, leadership of CDMOs, and strong knowledge of regulatory expectations; teleworking up to 2 days per week; fluent English.

Qualifications

• PhD in Formulation or advanced formulation engineering degree.
• Minimum 10 years in CMC across multiple clinical studies (Phase 1–3).
• Fluent English is essential.
• Extensive experience in Good Manufacturing Practices (cGMP).
• Experience in managing a CDMO.
• Technical leadership in formulation, manufacturing process and project management for development programs.

Responsabilités

• Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a formulation expert.
• Carry out CMC quality reviews (module 3) of product and project dossiers as an in‑house expert, and provide drug product expertise as part of Due Diligences.
• Review and validate QOS and variations requiring formulation expertise.
• Analyze and appraise product issues relating to formulation & manufacturing, and assess the work required to resolve them.
• Provide formulation and manufacturing expertise for all requests, as well as technological and CMC watch.
• Be responsible for the CMC Work Package for new projects, in cross‑functional collaboration with clinical, non‑clinical, research, regulatory, quality and other departments.
• Monitor work in line with this strategy, in terms of quality/cost/timeframe, with internal departments and subcontractors, and provide expert support and scientific guidance to CMC subcontractors.
• Represent Pierre Fabre's formulation & manufacturing expertise to the authorities in case of questions.
• DRAFT AND/OR CHECK the CMC part of INDs/IMPDs/NDAs/MAAs, including questions and answers to the authorities.
• Define and manage the formulation & drug product manufacturing budget for all development phases.
• Support as formulation expert internal life‑cycle management programs and regulatory changes for assets and raw materials.

Connaissances

CMC expertise

Formulation leadership

CDMO management

English fluency

Formation

PhD in Formulation

Description du poste

Who we are

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 solid and sterile Formulation 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 solid and sterile formulation, manufacturing support, scale‑up process and technology transfer of the drug product, characterization of the drug product process steps, development of the activities for validation, definition of specifications and process validation.

• Propose a pharmaceutical strategy in line with its CMC expertise and ensure that it is transcribed into dossiers as a formulation expert.
• Carry out CMC quality reviews (module 3) of product and project dossiers as an in‑house expert, and provide drug product expertise as part of Due Diligences.
• Review and validate QOS and variations requiring formulation expertise.
• Analyze and appraise product issues relating to formulation & manufacturing, and assess the work required to resolve them.
• Provide formulation and manufacturing expertise for all requests, as well as technological and CMC watch.
• Be responsible for the CMC Work Package for new projects, in cross‑functional collaboration with clinical, non‑clinical, research, regulatory, quality and other departments.
• Monitor work in line with this strategy, in terms of quality/cost/timeframe, with internal departments and subcontractors, and provide expert support and scientific guidance to CMC subcontractors.
• Represent Pierre Fabre's formulation & manufacturing expertise to the authorities in case of questions.
• DRAFT AND/OR CHECK the CMC part of INDs/IMPDs/NDAs/MAAs, including questions and answers to the authorities.
• Define and manage the formulation & drug product manufacturing budget for all development phases.
• Support as formulation expert internal life‑cycle management programs and regulatory changes for assets and raw materials (i.e. manufacturing equipment changes, new sourcing of raw material, manufacturing process optimization…).

This position is compatible with teleworking up to 2 days a week according to company rules.

Benefits

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
• Very attractive CE…

Nous offrons un package rémunération/avantages attractifs :

• Intéressement
• Participation
• Actionnariat Pierre Fabre avec abondement
• Mutuelle santé et prévoyance
• 16 RTT en plus des CP
• Participation transport collectif
• CE très attractif…

Who you are

Formulation engineer or PhD in Formulation

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 formulation, manufacturing process and project management associated with development programs is required.

Ingénieur formulation ou Doctorat en formulation/galénique

Minimum 10 ans d’expérience dans de l’expertise CMC acquise au travers de plusieurs études cliniques (phase 1 à la phase 3), idéalement jusqu’à l’enregistrement.

Anglais courant indispensable.

Vous bénéficiez d’une vaste expérience en matière de bonnes pratiques de fabrication (cGMP).

Vous avez géré un CDMO.

Expérience nécessaire de direction technique en formulation, procédé de fabrication et de gestion de projets associés à des programmes de développement.

Equal Employment Opportunity

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 healthcare. 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.