Manufacturing Associate II

Manufacturing Associate II 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. The Manufacturing Associate II is responsible for supporting the overall cGMP upstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. This is a full-time, on-site hourly position. Shift schedule is 7:00am to 7:00pm (2 days on, 2 days off, 3 days on rotation). Alternating weekend work is required. Catalent’s FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines. 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 Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP Generate and revise internal and external documents (SOPs, BRs.) Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs Troubleshoot process and equipment problems Work with Facilities and Validation to maintain manufacturing equipment Other duties, as assigned The Candidate Requires Bachelor’s degree in a Scientific, Engineering or Biotech field with a minimum of 1-3 years’ experience with Upstream (fermentation/bioreactor) or Downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate’s degree in a Scientific, Engineering or Biotech field with a minimum of 2-4 years’ experience with Upstream (fermentation/bioreactor) or Downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR High School Diploma or GED with a minimum of 4-7 years’ experience with Upstream (fermentation/bioreactor) or Downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance Prior experience in cGMP upstream biopharmaceutical manufacturing, highly preferred Prior experience with TFF (tangential flow filtration) and biomanufacturing harvest clarification, highly preferred Experience working in an aseptic environment, highly preferred

Salary : $58,000 - $80,000