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Analytical laboratory manager

Descriptif de la mission

• Define your team's annual objectives in line with the Product Development objectives, lead your team by mobilizing them around their objectives, define and implement the work organization and ensure information, communication and participate in the development of the teams' skills
• Provide technical support to scientific/ laboratory management activities:
- Ensure the design of the analytical development studies entrusted to you, their realization, the evaluation of the results and their communication in the form of study reports, in compliance with the defined deadlines, the regulatory requirements and at an optimal cost.
- Provide expertise in area of analytical methods development, validation and transfer, stability program, formulation and process development analytical support at each development phase from clinical phase I to commercial launch.
- Provide expertise to troubleshooting for the mostly utilised analytical techniques (HPLC, UPLC, dissolution…).
- Participate in the definition and implementation of the strategy and selection of subcontractors.
- Propose and implement innovative and high value-added solutions that could lead to the filing of patents.
- Contribute actively to the writing of specific sections of the regulatory files dossier (IMPD, IND, NDA and MAA) corresponding to the studies for which you are responsible and ensure the technical responsibility.
- Anticipate the needs in resources (technical and human) necessary for the good functioning of the unit and propose recommendations. Ensure the development and evolution of new techniques and methods by proposing the purchase of new equipment and supervise their use and evolution.
- Ensure and maintain close collaboration with existing global analytical community.
- Ensure the management of equipment (maintenance, qualification, investments...)
- Ensure and maintain GMP compliance of the laboratory.

Critères requis

Education / Certifications:
• Scientific background (Master/ Engineer degree / Pharmacist) with a PhD in chemistry, analytical sciences, drug quality control…

• Ideally 10 years’ experience in pharmaceutical Development Industry on pharmaceutical development projects for small molecules or peptides from phase I to commercial launch.
• Solid experience in team management, with a marked sensitivity to develop the team in the face of change.
• Experience of working in international environment.
• Experience of project management.
• Strong expertise of analytical techniques and of standard pharmacopeia methods (HPLC, UPLC, dissolution…).
• Strong knowledge of BPF and cGMP.
• Significant experience in development of pharmaceutical products in Europe and in USA including writing of regulatory dossier.
• Ideally, experience in Quality by Design methodology and risk analysis.

• Fluent English is mandatory to ensure efficient interface with international CMOs.