Head of CMC

Location: London, England Salary: £85000 - £120000 per annum + Bonus + Benefits
Sector: Pharmaceuticals Specialism:
Type: Permanent Contact: Chris Vowles

Role is to manage the companies CMC function. Senior role with wide ranging responsibilities. Requires an experienced person with a wide skills set, good organisational abilities and creative flexibility when it comes to problem solving. Also looking for someone with good interpersonal skills for working closely with other teams (in particular clinical and regulatory) as well as for managing relationships with key suppliers.

Key activities include:

1) Monitoring, scheduling etc drug substance manufacturing - biological drug made for ongoing phase 2 and imminent phase 3

2) Drug product manufacturing

3) Assays

4) Formulation - looking to move to a higher concentration

5) Delivery mechanisms - potential pen injector

6) Next generation - will want to tech transfer to larger scale manufacturer and looking at a higher yielding strain

7) New products - investigating a wide range of engineered products and new molecules which need to move to GMP manufacturing.

8) Regulatory - working closely with the regulatory team to produce IMPD, respond to questions etc

9) Approvals - given timelines need to move to a validation and process characterisation program reasonably soon

10) Trial distribution - have three trials running and 5 patients on long term safety programmes

11) Stok management - ensuring there is sufficient product, correctly labelled, appropriate stability etc for clinical trials

12) CMC strategy - given the number of trials, range of molecules etc within a small company - managing and developing the whole CMC strategy is critical

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.