A fast growing US Pharmaceutical company is actively seeking a Senior Director CMC analyst due to their successful company growth and dedication allowing them to expand their UK site. The role would report directly into the VP of Technical Operations & CMC and would be responsible for leading collaboration with global CDMOs and ensuring the smooth running of CMC activities. This is an excellent opportunity for some one who is up for a challenge and wants to specialise in 1 product while seeing it advance through its whole life cycle.
- Lead contact with CDMOs while also being responsible for evaluation and recommendation
- Prepare and review relevant regulatory submissions and interactions
- Lead analytic development and validation for drug substance and drug product
- Assure proper quality standards are maintained
- Experience in a CMC leadership position with filing experience, writing INDs, IMPDs, NDAs and MAAs
- In-depth knowledge of and Good manufacturing practice (GMP) and International Conference on Harmonisation (ICH) guidelines
- Experience in dealing and communicating with CDMOs / CMOs
- Ability to multi-task a variety of projects and activities, balancing scientific, operational and strategic risk
If you are interested in this opportunity, please apply with an updated CV and contact details.