Formulation Expert in solid and sterile pharmaceutical forms

Pierre Fabre Laboratories; Toulouse; Hybride; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Pierre Fabre Laboratories seeks a Formulation Expert for its Toulouse site to lead solid and sterile formulation development on a permanent contract. You will drive strategy, supervise CMC activities, and coordinate with regulatory, quality, and clinical teams to ensure successful drug product development and tech transfer.

The role requires at least 10 years in CMC with strong leadership in formulation and manufacturing processes, and experience managing CDMOs within cross-functional

Qualifications

• Minimum 10 years of CMC experience gained through multiple clinical studies (phase 1–3).
• Extensive experience in cGMP manufacturing practices.
• Experience managing a CDMO.
• Technical leadership in formulation, manufacturing processes and project management.

Responsabilités

• Propose a pharmaceutical strategy aligned with CMC expertise and translate into dossiers as a formulation expert.
• Carry out CMC quality reviews (module 3) of product and project dossiers.
• Review and validate QOS and variations requiring formulation expertise.
• Analyze and appraise issues related to formulation and manufacturing; define resolution steps.
• Provide formulation and manufacturing expertise for internal requests and CMC watch; lead CMC Work Package for new projects.
• Collaborate with clinical, regulatory, quality and other departments; guide subcontractors.
• Represent formulation and manufacturing expertise to authorities; draft/check CMC parts of INDs/IMPDs/NDAs/MAAs.

Connaissances

CMC expertise

Formulation leadership

Process development

Project management

Regulatory submissions

Description du poste

We are recruiting a Formulation Expert in solid and sterile forms 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.

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 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.
• You 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. 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 formulation & manufacturing 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 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.

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:

Minimum 10 years of experience in CMC expertise acquired through several clinical studies (phase 1 to phase 3), ideally up to registration.

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.