- Define and obtain management approval for the business cases for new product and LCM industrialization, including financial and regulatory aspects, in order to anticipate industrial resource and investment needs.
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Define the strategy for transferring processes to production and the process validation strategy in compliance with GMPs.
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Organize monthly industrialization meetings with the industrial teams to provide visibility on new products and LCM/support activities.
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Define the budget for studies, operating expenses, and capital expenditures, as well as resource allocation and priorities.
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Assess and escalate project-related risks, liaising with various departments: R&D, Regulatory Affairs, Procurement, Franchise, and Management Control.
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Promote and lead the QbD design and experimental phases. Ensure the day-to-day implementation of QbD through the definition of QTPP, CPP/CQA, and FMECA.
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Develop synergy between the Laval and Loudéac teams by pooling efforts and technical expertise in analytics/processes (HPLC, PAT, NIR, Raman, etc.) and methodology (DoE, statistical analysis, Minitab, capability, etc.).
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Ensure the management of GID laboratories (HSE, teams, etc.) and prepare for future initiatives: open lab, pilot unit.
Your profile :
Education and Experience:
You have a science degree (Master’s level) and 5 to 10 years of industry experience, ideally at pharmaceutical sites (GMP/cGMP environment).
Technical Skills:
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You have solid knowledge of manufacturing processes for solid and semi-solid oral dosage forms and experience with extrusion processes.
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You are comfortable with office software and are fluent in written and spoken English.
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You have demonstrated your managerial skills by leading teams.
Soft Skills:
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You demonstrate adaptability, dynamism, and responsiveness.
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You are proactive and capable of cross-functional collaboration.
Your Benefits at Ceva:
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Meal vouchers (face value €10.33, with 60% covered by the company)
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Time Savings Account
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Profit-sharing, Employee Stock Ownership Plan, and an attractive Company Savings Plan
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Health insurance and retirement benefits
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Employee Committee benefits and an association offering activities on campus (yoga, fitness, cooking classes, creative arts, etc.) and off campus (after-work events, indoor soccer tournaments, etc.)
Wondering what our campus looks like? Here it is: https://www.youtube.com/watch?v=NF8k6qsxj4s&t=7s
And what’s Laval like? https://www.calameo.com/read/005078094d94cecbcde40
