Senior Analytical Chemist, Specialty Sciences

Senior Analytical Chemist, Specialty Sciences

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Senior Analytical Chemist, Special Sciences performs routine and non-routine elemental impurities testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. The Senior Analytical Chemist, Special Sciences will provide laboratory troubleshooting for a team to assist in the successful and timely execution of laboratory analyses.

The Role

• Independently  perform  routine  and  complex  testing  using  ICP-OES,  ICP-MS  and  Atomic  Absorption  (Graphite Furnace and Flame) for analysis of excipients, new chemical entities and/or drug products.

• Interpret data and make recommendations to management for improvement or potential concerns.

• Compare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirements.

• Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation.

• Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations.

• Independently  author  standard  operating  procedures,  analytical  testing  procedures,  final  submission  ready documents, and create document templates for use by junior team members.

• Identify and recommend opportunities for improved efficiencies, internal/external client service and teamwork within the analytical group.

• Serve as a point of contact for laboratory testing support and provide updates to laboratory supervision and/or client.

• All other duties as assigned.

The Candidate

• Associate degree in Biotechnology, Chemistry or equivalent science degree with 7 years of professional experience in pharmaceutical analytical chemistry or;

• Bachelor’s degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 6 years of professional experience in pharmaceutical analytical chemistry with emphasis in metallic analysis or;

• Master’s degree in a science-related field with 5 years of professional experience in pharmaceutical analytical chemistry with emphasis in metallic analysis or;

• PhD in a science-related field with 4 years of relevant experience in pharmaceutical analytical chemistry with emphasis in metallic analysis.

• At least 3 years of experience with elemental impurities testing required.

• Position requires the ability to lift 10-50lbs, unassisted.

• Majority of the work day is performed while standing, walking, lifting, pulling, and pushing.

• Requires bending, squatting, crawling, climbing, reaching.

• Some exposure to hazardous chemical and other active chemical ingredients.

Why You Should Join Catalent