Chemistry CMC Manager
We are currently looking for an experienced Chemistry CMC Manager to join a leading biopharmaceutical company based in Cambridge. This position will involve supporting outsourced manufacturing and development activities of drug substances and drug products.
Duties and responsibilities
As the Chemistry CMC Manager your duties and responsibilities will be varied but your main duties will involve:
- Supporting outsourced manufacturing and development operations such as providing oversight and expertise for small molecular and solid phase peptide synthesis and scale up.
- You will oversee drug formulation development and stability studies and be responsible for reviewing and approving MBR's, protocols and technical data.
- As the Chemistry CMC Manager you will develop specifications and analytical methodology for characterisation and release of drug substances and products.
Education and Experience
We are looking to identify the following skills and experience in your profile to be a successful applicant:
- MSc or PhD in Chemistry or a relevant scientific discipline and experience in industry working in a CMC function.
- Proven industry experience in CMC, preferably chemistry, managing CDMOs and ensuring optimal delivery of projects.
- Industry experience in writing quality modules for regulatory submissions.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales