Company: Key People Limited
Location: Frankfurt am Main
Closing Date: 08 Dec 16
Salary (£): 80,000 - 100,000
An excellent opportunity has arisen for a CMC Project Manager to join an independent research-based biotechnology company on a 6 month contract basis. The ideal candidate will have a strong CMC and Biologics background - this is essential!
An excellent opportunity has arisen for a CMC Project Manager to join an independent research-based biotechnology company on a 6 month contract basis. The ideal candidate will have a strong CMC and Biologics background – this is essential!
· Alignment of the CMC development strategy
· Identification and risk assessment of the quality attributes
· Monoclonal antibody experience would be beneficial
· Project planning, monitoring and coordination of subcontractors
· Support for demand planning and coordination of the packaging / labeling by the external partner
· Creation, review and approval of label texts
· Preparing the release of samples by the Qualified Person
· Organization of temperature controlled transports to study centers and the country-depot
· Evaluation of the transport temperature and processing variations
· Preparing and reviewing SOPs
· Scientific degree
· CMC experience in the development of Biologics
· At least 5 years of professional experience in production of investigational medicinal products
· Expertise in project management, quality management and risk management
· Excellent knowledge of GCP and / or GMP requirements for clinical test samples
· Organizational skills, communication skills and independent and structured way of working
· Very good English language skills, verbal and written
For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org
|Tel:||Tel: 44 (0) 1727 811634|
|Fax:||Fax: 44 (0) 1727 844838|
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