Director / Senior Director Analytical Cmc

7 days ago


Kent, United Kingdom SciPro Full time

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 & CMCand 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 throughits whole life cycle.

Main responsibilities:

- 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

Key Experience:

- 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


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