High Potency API Specialist Role
We are seeking a highly skilled High Potency API Specialist to join our team. The ideal candidate will have in-depth knowledge and expertise in the safe handling and development of high potency active pharmaceutical ingredients (HPAPIs).
Job Description
The HPAPI Specialist will be responsible for leading the development of new and existing chemical processes for HPAPIs. This will involve cross-functional collaboration with operations, project management, quality, and safety groups as well as with customers. The successful candidate will work closely with our R&D team to support all aspects of new product introductions, process development, process safety, process monitoring, and troubleshooting.
This role will also involve working with a team of R&D chemists to lead development projects in the high containment laboratory. The candidate will identify and implement new technologies to support business needs and collaborate with operations engineers to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the manufacturing plant.
The HPAPI Specialist will also be responsible for collaborating with analytical R&D chemists to ensure that appropriate methods are in place for updated procedures. They will work cross-functionally to ensure that project milestones on HPAPI projects are delivered as per the project plan and assist in the preparation of Request for Information and Process RFI/RFPs for new product introductions.
The successful candidate will have experience in synthetic organic chemistry and hold a PhD in organic chemistry or chemical engineering with 5 years of practical lab experience. They will also have technical know-how on handling complex APIs or Hi-potency APIs (HPAPIs), experience in a GMP kilo lab in the pharmaceutical industry, and significant experience in the manufacture or development of linker payloads.
Required Skills and Qualifications
* Technical know-how on handling complex APIs or Hi-potency APIs (HPAPIs)
* Experience in a GMP kilo lab in the pharmaceutical industry
* PhD in organic chemistry or chemical engineering with 5 years of practical lab experience
* Significant experience in the manufacture or development of linker payloads
* Subject matter expert on the scale up of Chromatography, freeze drying, nano filtration, and Tangential flow filtration
Benefits
We offer excellent opportunities for career enhancement and personal development, a competitive base salary, annual bonus linked to business results, a well-established further education program, and a pension scheme. Our company provides private healthcare and encourages continuous learning and growth.