This position is responsible for management of the Process Research and Development Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing and early phase CTM services to the biopharmaceutical industry, including both API and Drug Product (DIC).
The position is responsible for managing all PR&D and related activities for all the above phases of development. The incumbent will work with a team of PR&D scientists in conjunction with the Analytical Chemistry department and assist in developing safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the incumbent will be the primary liaison with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and scale-up reports including batch production records (BPR’s) are completed in a timely manner and that standard operating procedures (SOP’s) are written and followed.
Experience / Education
Knowledge / Skills / Abilities:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability