Manufacturing Project Leader
ProClinical is working with a clinical stage Swiss biotech company seeking an experienced Manufacturing Project Leader who is responsible for support its product development programs. The Manufacturing Project Leader will be accountable to lead the development and manufacturing of Liposomal vaccines (drug product, nano-formulation) both in-house and with external partners (CMOs) for subsequent use in research, preclinical and/or clinical studies. The Manufacturing Project Leader will work within cross-functional teams in a matrix organization and interact with different stakeholders (Regulatory, QA, Research, Clinical dpt.) with final goal to achieve milestones of global programs on timely manner.
- Design and manufacture in-house new liposomal concept at small scale for research studies
- Define manufacturing process description and transfer of technology to CMOs
- Manage activities performed at the CMOs (screening & selection of appropriate CMOs, technical support, coordination of manufacturing activities)
- Support development of manufacturing processes, scale-up & manufacturing under GMP
- Ensure planning of manufacturing activities in-house and at CMO with tight coordination to ensure timelines are met
- Support budget preparation and control
Skills and Requirements:
- MSc or PhD in Material Sciences or Life sciences
- Has experience with nano-formulation (liposomes)
- Additional experience with peptide synthesis is a strong asset
- Has at least 5 years of experience in the pharmaceutical industry (drug substance and/or drug product manufacturing) which should cover: o Has demonstrated ability to lead a process development, scale-up and manufacturing activities to success and timely deliver related milestones
- Has demonstrated ability to independently plan, coordinate and complete complex projects within agreed budgets and timelines
- Ability to communicate clearly and efficiently at all levels, within the company and with external partners
- Strong team player
- Ability to integrate and learn fast o Self-motivating
- Fluency in English is a must; French and a third language are assets.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alannah Chauhan on +44 203 861 8210 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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