Summary of Position : This position requires formulation and process development experience with potential for future management responsibilities. The position is initially a hands on scientific role within the product development department; however, the successful candidate should possess the capabilities to be a future leader in the department.
Organization Structure: Product Development and Technology Transfer is a flat organization with all scientific and engineering positions reporting directly to the Director, Product Development Technical Transfer. Director Product Development Technical Transfer sits within Product Development and Technical Services which provides development services to the pharmaceutical industry in a CDMO company.
Responsibilities : Primary responsibilities of this role include the following:
Primary responsibility for the development of formulations for Phase II and beyond. These products can be:
New Chemical Entities (NCE) for NDA submission
Generic compounds for ANDA submission
Primary responsibility for developing a robust manufacturing process for same
Primary responsibility for all associated development reports; product and process
Primary responsibility for scale-up of developed formulations and processes
Primary responsibility for all associated scale-up reports
Responsible for representing PDTT in Project Team meetings; both internal and with customers
Qualifications : Successful candidate must have 5-10 years of relevant formulation and process development experience. Hands-on experience with set-up, operation, troubleshooting, and cleaning of R&D scale equipment. Extensive experience with formulation and process problem solving. A Masters degree in Pharmaceutics or Chemical Engineering is expected; however, a PhD degree is a preferred. Generic experience is a plus; however, a proven track record of successful product development experience is a key. Supervisory experience is not required, but leadership qualities are expected.
GMP Decision Making Authority : The successful candidate will be required to make decision about CGMP on a daily basis; both in the laboratory and Pilot Plant. CGMP documentation is a daily event.
Norwich Pharma Services
- 3 years ago - save job