Chemical Expert CMC

Laboratoires Pierre Fabre; Toulouse; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Incentives

Profit-sharing

Pierre Fabre shareholding

Health insurance

Provident insurance

Job summary

Laboratoires Pierre Fabre in Toulouse is seeking a Chemical Expert for CMC on a permanent contract. You will lead DS development and manufacturing for new drug candidates, including selection of synthesis routes, scale-up, tech transfer, and DS impurity characterization.

The role requires drafting quality modules for regulatory submissions and collaborating across clinical, regulatory, and quality teams. You will drive the CMC strategy, manage budgets, and provide expert guidance to outsourcing

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.
• Extensive experience in Good Manufacturing Practices (cGMP).
• Experience of managing a CDMO.
• Experience of technical leadership in chemistry and project management associated with development programs.

Responsibilities

• Develop and manufacture drug substance (DS); optimize small molecule synthesis routes and tech transfer.
• Support scale-up, process validation and DS characterization of impurities and RSMs.
• Lead CMC strategy, prepare module 3 quality reviews and DS portions of regulatory dossiers (INDs/IMPDs/NDAs/MAAs).
• Define and manage chemistry budget across development phases.
• Provide scientific guidance to CMC Outsourcing Managers and interact with authorities as needed.

Skills

CMC expertise

GMP / cGMP

Project management

Technical leadership

Regulatory knowledge

Education

Chemical engineer

PhD in chemistry

Job description

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 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:

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.

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.