Lupin Pharmaceuticals, Inc.
Senior Technical Operations Scientist (R&D)
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women's health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
The Senior Technical Operations Scientist reports directly to the Director of Technical Transfer and is responsible for executing and coordinating product and process transfers, new product launches, scale up, validations, revalidations, hold time studies, root cause analyses, and continuous process improvement activities. Scientist must assimilate, review / analyze formulations and process data to assist Product Development with formulation development and process development. Work tasks include: experimental design, documentation of experimental plans, preparation of experimental batch records, execution of experimental plans and engineering trials, formal reporting of experimental / investigational data, and commercial batch records. Organize and maintain relevant technical operations documents. This Scientist will also participate in regulatory submissions (CBE, PAS, AR), patent projects with Legal, and OpEx initiatives.
PHYSICAL ENVIRONMENT
The physical requirements of the position include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, use of vision, talking, and hearing. Frequently, bending, kneeling, crouching, stooping, climbing ladders/stairs, and crawling apply. The position requires reading documents, working on a computer with keyboard and mouse, discerning colors, discerning feel of textures, manipulating small dosage units, and using a magnifying glass. Work is performed both in an office and manufacturing environment. Ability to wear safety shoes, eye protection, and using respirators are required.