Associate Scientist, QC Microbiology

Associate Scientist, QC Microbiology

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 Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Associate Scientist, QC Microbiology will assist with the end-to-end contamination control and sterility assurance practices for Catalent’s aseptic production process. This position will support the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, compliance to regulations and standards in the subject of sterility assurance and contamination control. The Associate Scientist will work both independently and with the team to perform routine and non-routine microbiological testing, environmental monitoring, and/or microbiology laboratory maintenance functions, where necessary. 

This position is 1st shift M-F 8AM-5PM and 100% on site at Harmans/BWI, Maryland facility.

Catalent 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: 
• Ensure testing compliance meets the requirements of ISO, USP, EU, CFR, cGMP, and GLP in the Microbiology laboratory at all times; document laboratory test results utilizing Good Documentation Practices. 
• Perform routine and in-process environmental monitoring in Grades A, B, C, and D environments, including areas where full aseptic gowning is worn for extended periods of time; conducts sampling and testing of utilities such as USP water, WFI, clean steam, and CCA/Gas. 
• Maintain the Micro labs in a state of audit readiness; ensure daily or weekly maintenance of all Micro laboratory instrumentation and media usage dates; provide accurate product, raw material, and Environmental monitoring microanalysis data. 
• Perform Bacterial Endotoxin testing using the kinetic chromogenic method; perform bioburden testing using membrane filtration for cleaning, in-process, buffer/media, and release samples; perform growth promotion of microbiological media; perform microbial isolation techniques, subculturing, and gram stain identifications. 
• Send out samples to contract labs and track results/reports; perform general laboratory cleaning/wipe-down; maintain lab inventory and partner with management to request order lab supplies and materials to be ordered. 
• Support continuous improvement projects related to QC; support the revision of controlled documents such as Standard Operating Procedures and controlled forms; assist with investigations, change controls, and CAPAs associated with microbiological testing; support data trending and tracking of results. 
• Communicate effectively with QC peers, cross-functional peers, and management; actively participate in training activities and managing individual training plan. 
• Other duties as assigned. 

The Candidate: 
•    Bachelor in a Microbiology, Biology, or related discipline required with experience working in a cGMP QC laboratory preferred. 
•    Knowledge of cGMP, familiarity with Quality Tools such as SPC and Root Cause Analysis, FMEA, HACCP, and technical writing skills. 
•    Demonstrate knowledge of scientific understanding of microbiological methods; demonstrated ability to investigate and identify causes of suspect laboratory results; comfortable working in cleanroom and BSC environments in aseptic gowning for extended p