CMC Process Development Lead – Remote with occasional visit to our clients West Wales site and overseas
Up to £50k + up to 20% bonus and other benefits!
Our Client, a highly reputable Pharmaceutical company is looking for a CMC Lead to join their team on a permanent basis!
- To lead the CMC team in process development project work to support manufacturing and commercial activities of new and established biological products.
- Represent the CMC team at team meetings and provide expert process development advice.
- Develop novel methodologies to support new and existing manufacturing processes. Apply mathematical and statistical modelling (knowledge of DoE) to validate scaled-down process models and define process limits.
- Potential to transfer new small-scale methodologies and techniques to production scale.
- Input into the Regulatory strategy and author the relevant sections of Regulatory dossiers.
- Supervise the process development team and laboratory to ensure studies are performed to the highest standard.
- Responsible for developing, supervising, and training scientists within process development.
- Experience with AKTA unicorn software, tangential flow filtration, viral filtration, etc desirable
- Represent the company at external seminars and supplier visits as required.
- Input into the formulation of budgets related to projects and departments.
WHAT WE NEED FROM YOU
- Educated to degree level in an appropriate scientific discipline.
- Significant experience in analytical development for biologics.
- Experience in working with contract laboratories.
- Please note this position does not offer sponsorship
WHY YOU WILL LOVE WORKING HERE….
- Fantastic company culture
- Fast-paced and ever-changing environment where people work as a team
- Excellent salary package incl bonuses and private healthcare