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Contenu de l'offre Product Development Manager chez RBW Consulting
Product Development ManagerProduct Development Manager
Clermont-Ferrand, France
Potential remote working
RBW Consulting are delighted to be supporting an innovative Pharmaceutical ophthalmology company based in Clermont-Ferrand with their search for a Product Development Manager. The group is a leader in several therapeutic classes as well as in the field of preservative-free eye drops, dedicated to developing high-quality products that support ophthalmic care and eye health across more than 70 countries.
The Product Development Manager will manage the implementation of open innovation projects and to evaluate the galenic, analytical and industrial process development of open innovation projects in line with the Innovation and R&D strategy, in compliance with current regulations, Good Practices and health and safety rules, in order to expand the range of group's products
Responsibilities
Gather as much CMC/Regulatory/Industrial information as possible and carry out a full risk and opportunity assessment of the project concerned to ensure the viability of the project.
Evaluate the mitigation plan for the critical areas of the project.
Provide input to validate or invalidate the feasibility of open innovation projects.
Evaluate the external development of galenic, analytical and pharmaceutical projects within the deadlines defined by R&D.
Review, amend and evaluate protocols, studies and study reports.
Define the planning of analytical, process and microbiological subcontracting.
Conducting CMC (Chemical and Manufacturing Controls) evaluation of new programmes.
Provide support for the drafting of the pharmaceutical dossier.
Develop microbiological studies and adapt sterilization methods or other treatments.
Define the industrial work in collaboration with the CDMO/CMO.
Validate the critical steps impacting the timing/budget in collaboration with the CDMO/CMO.
Requirements
Bachelors Degree in a Scientific Discipline.
10 years experience in the Pharmaceutical industry.
Strong experience of early stage R&D.
Good working experience and knowledge of CMC.
Ability to detect project risk.
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