Operator I, Formulation Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Drug Substance - Operations department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.The Formulation/Support team executes GMP formulations of various growth production medias and feeds to support the upstream process, as well as a variety of different buffers and sanitization solutions to support the downstream purification process. The Formulation Department utilizes Master Batch Records and SOPs in a cGMP environment, focusing on 'right first time' and on-time delivery for each formulation.
The Operator I, Drug Substance is responsible for the formulation of GMP solutions (liquid medias/feed, buffers, sanitizing solutions) using Raw Materials that are consumed/used throughout the upstream and downstream processes. This is a fulltime position working 12 hours 6PM - 6:30AM on a 2/2/3 rotationCatalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Role- Follows detailed Batch Record and procedures to formulate drug substance
- Performs aseptic techniques within in a clean room environment; safely operates Single Use Mix tanks to support large-scale formulations, as well as required equipment for small scale batches (