Director R&D Biology Analytical Development and Process H/F
Job Description:
Reporting to the R&D Biology Director, you will lead the development of Part II (Quality/CMC) of our immunological products for Europe and international markets, with a view to their industrial transfer and registration. As a true strategic partner, you will also lead the evaluation and pre-development of biological products within the framework of Licensing opportunities or new technological platforms.
Your missions:
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CMC Strategy & Development: Lead the development of processes (USP, DSP, Formulation) and analytical methods, from the exploratory phase through clinical batch production, industrial transfer, and registration (writing Part II of the MAA dossier), in compliance with GMP standards and the Pharmacopoeia. *
Industrialization & Transfer: Ensure the structuring of industrial transfers to Production and Quality Control. You will collaborate closely with the MSAT department and regulatory affairs to define industrialization plans and support the manufacturing of commercial batches. *
Strategic Evaluation & Licensing: Advise Management by technically and economically evaluating external opportunities (Due Diligence, innovative platforms). You will analyze risks (timelines, costs, industrial viability) to guide investment decisions. *
Management & Leadership: Define the organization of your department, supervise, unite, and develop your teams (managers and technicians). You will manage and optimize resources (OPEX/CAPEX) according to Group priorities. *
Innovation & Watch: Stimulate innovation by identifying new technologies (process, formulation, and analytical) to optimize our methods, reduce production costs (CoG), and anticipate regulatory evolutions. *
International Network: Provide high-level scientific and technical support to Virbac subsidiaries and Joint-Ventures as part of their local developments.
Profile sought:
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Education: Pharmacist, Engineer and/or PhD in pharmaceutical bioprocesses, cell biology, virology, and/or bacteriology. *
Solid experience (min 10 years) in biopharmaceutical process development (USP, DSP, formulation, analytical, industrialization) in a GMP-regulated environment. *
Proven managerial skills, with a strong ability to mobilize, empower, and develop multicultural and cross-functional teams. *
Excellent mastery of regulatory requirements related to biological products and the writing of MAA dossiers (vaccine and biopharma). *
Visionary profile with a strong critical mind, demonstrating leadership, managerial courage, and a perfect mastery of economic and business issues. *
Fluent English (spoken and written) is essential to operate in an international context.
Our benefits?
Fixed remuneration and benefits (various bonuses, profit-sharing and incentive schemes, health and life insurance, CSE benefits, participation in company meals).
Based in Carros (06)
For candidates from outside the region, we support your geographic mobility through a mobility pack which includes:
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assistance in searching for your new accommodation, *
financial support, *
coverage of your moving expenses.
Why not you?
Joining Virbac means joining one of the world leaders in animal health. Our international dimension, coupled with a work environment that encourages development, initiative-taking, and creative energy, will boost your professional career.