Recruiter: Hays Recruitment
Salary: £60,000 - £80,000
Application date: 9th Jul 2019
Your New Company/Job:
An Innovative and rapidly expanding biopharma, creating complex cell therapy platforms to help patients suffering from a wide range of cancers. The company is building a team of talented and motivated people to pursue a collective mission, “cure cancer”. We are currently looking for an Operations Manager, with strong and demonstrable leadership skills, who will join the Manufacturing Group to buildout the facility, hire and lead a team from the ground up to manufacture genetically engineered T cell products .
• Manage and coordinate the buildout of the GMP manufacturing facility to meet FDA, EU and MHRA guidelines.
• Hire, train and manage the core manufacturing and quality control teams.
• Serve as the technical resource for all aspects of the T cell GMP manufacturing process.
• Ensure conformity to the Quality Management System and release drug products in a timely manner.
• Prepare, review and revise SOPs and manufacturing reports.
• Liase with the Facility Management for coordination of manufacturing activities and warehousing of raw materials.
• Review manufacturing and quality control records
• Assist in the forecasting budget and determine resource requirements
• Ph. D. in biological sciences or related field and minimum of 7 years progressive experience in a cell therapy or related field in GMP manufacturing.
• Expert knowledge and ability to apply GMPs in conformance with EU, FDA and/or ICH standards.
• Experience with T cell therapy manufacturing preferred or an strong immunology background.
• Outstanding interpersonal communication and organizational skills.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Comfortable in a fast-paced small company environment with minimal direction.