High Potency API Specialist
This is a highly skilled and technical role that requires expertise in the safe handling and development of High Potency APIs (HPAPIs). The specialist will work with a team of R&D chemists to lead development projects in the High Containment Laboratory. This may include route scouting and development, completion of proof-of-concept studies, crystallisation optimisation, and process safety assessments as required.
The successful candidate will be responsible for identifying and implementing new technologies to support development for the business needs of the site. They will collaborate with Operations engineers to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the manufacturing plant and with analytical R&D chemists to ensure that appropriate methods are in place for updated procedures.
They will also work cross-functionally to ensure that project milestones on HPAPI projects are delivered as per the project plan. The specialist will be a key member of the high potency audit team and assist in the preparation of Request for Information and Process RFI/RFPs for new product introductions (NPIs).
The ideal candidate will have experience in synthetic organic chemistry and knowledge of Hi-Potent (HPAPI) handling systems. They will have a strong understanding of GMP regulations and quality management principles. A PhD in Organic Chemistry or Chemical Engineering is desirable, but not essential.
Key responsibilities will include:
* Leading development projects in the High Containment Laboratory
* Identifying and implementing new technologies to support development
* Collaborating with Operations engineers to ensure process development operations are successfully implemented in the manufacturing plant
* Working cross-functionally to ensure project milestones are delivered as per the project plan
* Assisting in the preparation of Request for Information and Process RFI/RFPs for NPIs
Excellent problem-solving skills and commitment to continuous improvement are essential for this role. The ability to communicate complex information effectively to colleagues and stakeholders is also crucial.