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.
Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent’s cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium.
The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy production.
The QC Scientist – Microbiology, Bio-Analytical and Raw Material is responsible for performing microbiological, bio-analytical and raw material testing to ensure the quality and safety of products. The position involves routine testing of raw materials, in-process samples, and finished products, as well as environmental monitoring and support for aseptic control. The QC Scientist will collaborate with cross-functional teams, participate in investigations of deviations and non-conformances, and contribute to continuous improvement initiatives. This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures (SOPs). Additionally, the QC Scientist will mentor junior staff, support audits, and ensure proper maintenance and calibration of laboratory equipment, playing a key role in upholding the laboratory’s operational excellence.
The Quality Control scientist must be able to help the team with Raw material work by being responsible for ensuring the quality and compliance of raw materials used in pharmaceutical manufacturing. This role involves creating material specifications, conducting identification tests, and performing assays and impurity analyses according to established protocols and regulatory requirements.
The Quality Control Scientist - Microbiology, Bioanalytical will report to the Supervisor, Quality Control.

• Perform sterility, endotoxin, microbial identification, and compendial testing (e.g., BacT, Endotoxin, Mycoplasma) on raw materials, in-process samples, and finished products.
• Conduct EMPQ, aseptic control, cleaning/disinfection, and environmental monitoring of laboratory and manufacturing areas.
• Analyze and trend EM/sterility data, prepare monitoring reports, and support investigations, CAPAs, and Change Control for microbiological deviations.
• Collaborate with QA, Manufacturing, and R&D teams to implement the site Microbial Control Strategy, perform growth promotion testing, support method development/validation, and ensure audit readiness.
• Maintain compliance with SOPs and regulatory requirements (FDA, EMA, cGMP) by documenting results, supporting audits, and ensuring equipment calibration and maintenance.
• Support lab operations by maintaining equipment, mentoring team members, managing supplies, and demonstrating strong problem-solving, communication, and teamwork skills with eagerness to learn and take on new responsibilities.
• Bioanalytical QC: Perform routine and non-routine bio-analytical testing on raw materials, in-process samples, and finished products using techniques such as ddPCR, Flow Cytometry, ELISA, Viability assays, and cell culture; analyze and interpret data to ensure accuracy, compliance, and assay performance.
• Support QC operations through SOP and documentation management, deviation/CAPA investigations, Change Controls, technology transfer, method validation/qualification, equipment maintenance, and cross-functional collaboration with Manufacturing and Quality Assurance.
• Other duties as assigned