CMC Project Manager Biologics

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We are looking for a senior expert to join an exciting project in late phase development

The purpose of this role is to develop and support projects in biological development and processes for clinical and commercial use.

Tasks:

Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development regarding CMC projects. Design, plan, perform and monitor all assigned drug product development activities Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members Interpret results, evaluate data, draw relevant conclusions, and write reports. Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.). Actively support generation of international registration documents for market authorization and interact with authorities where appropriate; act as technical expert in audits or inspections. Contribute to overall development strategies and improvement of operational excellence of business processes. Contribute to evaluation of new scientific technologies/equipment Coach junior team members. Requirements:

* PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge. * At least 5-10 years relevant experience in pharmaceutical industry including thorough understanding of late phase pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background * Thorough track record of process transfer, validation and regulatory submissions including health authority inspections. * In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage. * Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects

Michael Bailey International is acting as an Employment Business in relation to this vacancy.