Industrial Development Manager
il y a 3 semaines
Job Summary
Ceva Santé Animale is seeking a highly skilled Industrial Development Manager to join our team at the Laval site. As a key member of our industrial development team, you will be responsible for implementing our industrialization strategy and developing manufacturing processes for new products.
Key Responsibilities
- Define and obtain management approval for the rationales for industrializing new products and LCMs, including the financial and regulatory aspects, to anticipate industrial requirements in terms of resources and investment.
- Define the strategy for transferring processes to production and the strategy for validating processes in compliance with GMPs.
- Organize monthly industrialization meetings with the industrial teams to provide visibility on new products and LCM/support activities.
- Define the budget for studies, operating expenditure, and capital expenditure, as well as resource allocation and priorities.
- Assess and escalate the risks associated with projects, in liaison with the various business lines: R&D, Regulatory, Purchasing, Franchising, Management Control.
- Promote and manage the QbD design and experimental phases. Ensure the day-to-day implementation of QbD by defining QTPPs, CPPs/CQAs, and FMECAs.
- Develop synergies between the Laval and Loudéac teams by pooling efforts and expertise in analytical/process techniques (HPLC, PAT, NIR, Raman, etc.) and methodology (DoE, statistical analyses, Minitab, capability, etc.).
- Guarantee the management of the GID laboratories (HSE, teams, etc.) and prepare the tools of tomorrow: open lab, pilot unit, etc.
Requirements
- You have a scientific degree (Bac+5) and 5 to 10 years' experience in industry, ideally on pharmaceutical sites (GMP environment).
- You have a sound knowledge of manufacturing processes for solid and semi-solid oral dosage forms and experience of extrusion processes.
- You will be adaptable, dynamic, and responsive.
- You are able to make proposals and work cross-functionally.
- You are comfortable using office automation tools and have a good command of written and spoken English.
- You have demonstrated your managerial skills by supervising teams.
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