High Potency API (HPAPI) Specialist
Job Description:
The High Potency API (HPAPI) Specialist will require in-depth knowledge and expertise in the safe handling and development of HPAPI products. The role involves working with a team of R&D chemists to lead development projects, identifying and implementing new technologies, collaborating with Operations engineers and analytical R&D chemists, and ensuring project milestones are delivered as per the project plan.
Responsibilities:
* Work with a team of R&D chemists to lead development projects in the High containment laboratory.
* Identify and implement new technologies to support development for the business needs of the site.
* Collaborate with Operations engineers to ensure that process development operations demonstrated in the laboratory can be implemented successfully in the manufacturing plant.
* Collaborate with R&D project leads, project management group, and other functions such as SHE, Operations and Quality to ensure that project milestones on HPAPI projects are delivered as per the project plan.
* Key member of the high potency audit team.
* Assist in the preparation of Request for information and process RFI/RFPs for new product introductions (NPIs).
* Work with our customers on development projects to ensure that the final process taken to the manufacturing plant is understood, robust, efficient, in-control and meets their expectations.
* Act as product lead for specific API product(s), providing technical support for their manufacture.
Requirements:
* Technical know-how on handling of complex APIs or Hi-potency APIs (HPAPIs).
* Know-how of Hi-potent (HPAPI) handling systems starting with process isolation, to the use of the proper containment equipment, to the overall facility design, to personnel training, and finally PPE.
* Experience in a GMP kilo lab in the pharmaceutical industry of 5 years or more.
* PhD in organic chemistry or chemical engineering of 5 years practical lab experience.
* Significant Experience in the manufacture or development of linker payloads.