Formulation & Process Principal Scientist

Proclinical is seeking a dedicated Formulation and Process Principal Scientist to join a dedicated team in France. This role focuses on the development of pharmaceutical products, including injectable and oral forms, by developing formulations, selecting primary packaging, and defining the drug product manufacturing process. The successful candidate will be working within a collaborative and excellence-driven environment, ensuring compliance with regulatory guidance and company standards.

Responsibilities:

• Develop pharmaceutical products by formulating and choosing packaging.
• Define and plan development studies in collaboration with the analytical team.
• Ensure timely availability of required documents such as protocols, reports, and batch records.
• Present project results and progress at internal technical meetings.
• Manage the transfer and scale-up of drug product manufacturing processes.
• Lead the manufacturing of technical and formal stability campaigns.
• Provide continuous support to the manufacturing of clinical batches.
• Manage Drug Product CDMOs, including setting up contracts and monitoring performance.
• Collaborate with the Operational Quality Assurance team to review batch records and manage quality events.
• Represent the Formulation & Process function in CMC project meetings.
• Contribute to the writing of CMC sections for regulatory submissions.
• Ensure regulatory surveillance related to formulation and process activities.
• Apply Quality by Design principles from early development stages to dossier filing.
• Contribute to scientific literature and represent the company at scientific conferences.

Key Skills and Requirements:

• Degree in science or equivalent, ideally with a PhD.
• Strong knowledge of GMP and cGMP.
• Excellent communication and project management skills.
• Experience in CDMO management.
• Ability to work effectively in a matrix environment.
• Strong organisational and communication skills.
• Fluent in English.

If you are having difficulty in applying or If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.