VP CMC

Recruiter
Regulatory Professionals
Location
Cambridgeshire
Posted
10 Oct 2018
Closes
14 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
VP CMC Cambridge If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders. My client is looking for of Vice President CMC to manage the CMC management function and CMC strategy. Key responsibilities: Manage the CMC management function and CMC strategy for the portfolio, including oversight of primary, secondary and tertiary CMOs. Lead the internal CMC development teams. Oversee all work carried out at contract manufacturing organisations (CMOs) including the preparation of high expressing stable cell lines, cGMP cell banking and formulation development Adhere to standard methods and Standard Operating Procedures (SOPs) where applicable, and contribute to the development and drafting of new procedures as required Regulatory affairs activities with particular focus on regulatory compliance for clinical trials Experience: Ideally educated to PhD level in a relevant subject or BSc/MSc with equivalent industry experience Extensive previous experience in the management & delivery of internal and outsourced CMC activities for biopharmaceutical products Previous & demonstrable experience of implementing & maintaining a CMC system for the cGMP production of drug supply to clinical trials in line with regulatory & good-practice guidelines Previous experience of maintaining quality manufacturing standards & documentation for regulatory submissions Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to kirsty@regulatoryprofressionals.com or call Kirsty on 01189 522 797. We endeavour to come back to you within 24 hours of CV submission.

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