With a number of proprietary medicines either launched or in clinical development, an opportunity has arisen within the R&D department for an

Active Pharmaceutical Ingredient (API) Production Manager/CMC Manager

Playing an essential role during the life-cycle from route-scouting, process development and validation to commercial manufacture of API's, principal responsibilities will involve the management of outsourced production of API's at contract manufacturing organisations for use in both pre- and post-approved products, as well as the development and implementation of cost-effective API manufacturing processes.    

The successful candidate for this exceptional opportunity will hold an appropriate chemistry-related qualification, should have at least five years experience within the pharmaceutical industry and be able to demonstrate a proven track-record and thorough cross-functional knowledge of relevant API production activities, including:

• Current Good Manufacturing Practice for API's
• ICH and FDA guidelines relevant to quality and production of API's
• REACH legislation
• Drug Master File compilation
• Raw materials sourcing
• CMO qualification
• Cost of goods estimations
• Logistics
• Intellectual property

Excellent communication skills, fluency in English (both written and spoken) and computer skills are essential, as is availability to travel.

• Candidatar-se