CMC Specialist - Contract
A market leading Pharmaceutical company based in London are currently seeking a CMC specialist on a contract basis to support the global CMC aspects of projects within the company.
Key Accountabilities:
- Establish an external analytical laboratory for clinical trial release testing plus other work such as compatibility testing for iv or infusion kits.
- Early phase 1 studies including 1st in to man and radio labelled ADME studies CMC support
- Ensure appropriate products are developed for clinical trial use with sufficient stability data, test methods developed, manufacturing and pharmacy manuals transferred to CRO's etc.
- Writing and approval of the quality sections for IMPDs and INDs
- Support supply/development of products for Phase 2 and 3 clinical studies including over encapsulation of solid dose products for supply of comparators.
Role Criteria:
- Contractor Vendor Management will possibly be around 30-40% of the role Experience of working with contractors must be evident
- Experience of analytical methods, validation and method transfer
- Experience of supporting CMC aspects of early/first into human studies particulary using sterile or biological products
- Experience of preparation of the quality section of clinical trails application
- Minimum is BSC, in a subject such as Chemistry, biochemistry or pharmacy
- Someone comfortable with travelling in their role. Someone confident as they will have to be able to sit in front of vendors (probably sterile specialists) showing business awareness and scientific competence
- Working knowledge of cGMP and regulatory guidelines required
Key Words: Regulatry Affairs Regulatory Affairs specialist CMC CMC specialist contract RA clinical trials GMP IMPD IND chemistry pharmacy CMC pharmaceutical scientist London South East Pharmaceutical Hertfordshire North London West London Relocatable Middlesex CTAs Regulatory Affairs Manager Regulatory Affairs Senior Executive
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