Senior Manager - CMC/Manufacturing - Pharmaceutical

Barrington James Europe
London (Greater)
60,000 - 80,000
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
I am currently partnered with a rapidly growing and expanding Pharmaceutical company based in London. My client specialises within clinical supply manufacturing projects in which they currently have 6 compounds in development at various stages as well as 30 human studies in which they have a vast number of CMOs bidding for their products. They are looking to organically grow across Europe and are therefore seeking talented professionals who will help contribute to the continued success of their operations. Therefore, my client is now in need of a Permanent Senior Manager who will be directly reporting into the general manager, facilitating CMC and manufacturing duties for their ongoing clinical trials – helping them to build a continued successful operation. Responsibilities: Maintain regulatory CMC related documentation for ongoing clinical trials Review and re-author the quality section of the IMPD Maintain CMC content for Trial Master Files Review manufacturing documentation Ensure manufacturing projects occur within budget and a reasonable time frame Outline and review relevant SOPs to maintain compliance Monitor manufacturing project process and feedback to relevant stakeholders Requirements: Minimum 3-4 years’ experience in CMC Regulatory Affairs At least 5 years’ experience in Clinical Trial Development, Manufacturing and control of Pharmaceutical Products Educated to relevant healthcare or scientific degree level Knowledge of pharmaceutical technology, GMP, GDP, GLP and GCP. Strong oral and written communication skills with the ability to work effectively with multifunctional teams Substantial planning and influencing skills Highly detailed knowledge of EU regulations and guidelines for CMC, CTA and MAA for small biologicals and molecules There is no direct line-management within this opportunity, therefore providing the right candidate the chance to work freely and operate under their own initiative. If you feel this is the right position for you or are just eager to find out more then do not hesitate to get in touch on with me directly on; +44 (0) 1293 776644 or Alternatively, click here for my LinkedIn profile Also, click here to see what other opportunities I am currently working on