Job Reference: 0110JSCMC
Job Duration:
Start date: ASAP
Description:
CMC Development Manager, Cambridge
This is an exciting position within a global pharma company who are developing and commercialising drug products for a variety of therapeutic areas for use in markets across the world. The position requires strongexperience in pharmaceutical development and CMC with strong project management skills and CMO management. This company has a strong pipeline with products on the market and more to enter the market in 2019.
Salary & Benefits:
Excellent salary and benefits, details on application (please state your expectations in your application)
Role and responsibilities:
*Complete pharmaceutical development, including process validation programme
*Manage the supply of drug product and drug substances,meeting clinical development requirements and regulatory submissions
*Oversee technical CMC requirements for licence holders world-wide - supporting especially the tech transfer needs
*Involvement in labelling and packaging activities for pre-clinical as well as clinical trial medicines
*SOP creation - specifications, validation reports and batch records and NDAs in regulatorysubmissions
*Co-ordinate external vendors and controlling communication
*Communicate with manufacturing, pharmaceutical development, regulatory and other necessary external departments
*Working in accordance with GLP and GMP guidelines and maintaining relevant documentation
Requires skills and qualifications:
*Ideally 5 years' experience in pharma or biotech (or CRO/CMO)environments covering pharmaceutical development, CMC, formulation development, clinical trial supply manufacture, analytical development, quality control and stability testing
*Strong project management experience supporting manufacturing for clinical trials
*Working knowledge of the regulatory requirements - ICH guidelines in EU/US markets
*Strong GMP and GLP experience and hands on experience in working to requirements of quality management systems
*Excellent communication skills - managing externalvendors, CROs and CMOs
This is a fantastic opportunity for an enthusiastic and experienced R&D professional looking for career growth. The role offers outstanding development potential and will be the perfect match for someone with pharmaceutical development, project management and strong experience in technology transfer.
To apply for this position and put yourself underimmediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6600
Industry: Pharmaceuticals
Salary:
Salary Benefits:
Vacancy Type: Permanent
Job Skills: CMC, Development,R&D, Pharmaceutical, IMP, Project Manager, Laboratory, Tech Transfer, SOP, clinical, pre-clinical
Contact Name: John Spring
Website: -
Direct Application URL: -