The position will be responsible for managing the safe execution of chemical processes in the Kilo-Lab (Process Room suites) and Pilot Plant in compliance with cGMP regulations. The candidate will work with a team of operators in conjunction with PR&D and Analytical Chemistry Departments and assist in developing safe, efficient and easily scalable processes for producing raw materials, starting materials, intermediates, and active pharmaceutical ingredients (API’s), along with Powder-in-Capsule (PIC) products. In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process development and campaign reports including batch production records (MBRs/EBRs) are completed in a timely manner. This position has overall responsibility for keeping the Kilo Lab and Pilot Plant equipment and suites functional and compliant. The ideal candidate will have shown proficiency in hands-on chemical manufacturing and process safety work, the ability to manage activities and solve challenges, extensive experience reviewing and organizing chemical production data and leading a chemical production/engineering team. The position requires a strong background in drug substance production, as well as thorough knowledge of relevant equipment and cGMP, ICH and relevant FDA guidelines. CDMO experience is beneficial.
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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
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.