Associate II, Manufacturing

Associate II, Manufacturing Fill/Finish

Catalent Pharma Solutions is looking to hire a Manufacturing Associate II within our Fill/Finish team on 1st shift to support our Gene Therapy Team in Baltimore, MD.

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 FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.  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.

The Manufacturing Associate II Fill/Finish is responsible for supporting the overall GMP Fill Finish manufacturing processes in accordance with Good Manufacturing Practices (GMP).  Accountable for final formulation and filling for the manufacture of biopharmaceutical products under cGMP. Performs media simulation runs of processes as needed to ensure they are appropriately aseptic.

This is a full-time position and is 100% on-site. The schedule is Monday – Friday 7:00am to 3:30pm.

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

• Performs routine GMP manufacturing activities, including processing steps, aseptic filling, inspection, labeling, and equipment preparation.
• Assist in all areas of GMP clinical and commercial fill/finish activities. Includes, but is not limited to automated and semi-automated vial filling operations, vial inspection, vial labeling, media and associate qualification activities, etc.
• Completes and reviews GMP documentation and batch records accurately and promptly.
• Demonstrates knowledge of formulation, filling techniques, and associated equipment, including validation and maintenance.
• Prepares reagents, buffers, and equipment according to SOPs and batch records.
• Ensures compliance with internal controls, cGMP, and regulatory standards.
• Initiates and supports investigations for non-conforming events and corrective/preventative actions.
• Assists with equipment start-up, qualification, and validation activities. Troubleshoots equipment problems when necessary.
• Supports cross-functional GMP operations and may be cross-trained in additional processes.
• Actively participates in training and maintains an up-to-date individual training plan.
• Other duties as assigned

The Candidate

• Bachelor’s degree in a Scientific, Engineering or Biotech field with 2 years of experience with Fill Finish biologic production processes under GMP compliance.

OR

• Associate’s degree in a Scientific, Engineering or Biotech field with 2+ years of experience with Fill Finish biologic production processes under GMP compliance.

OR

• HS Diploma with 4+ years of experience with Fill Finish biologic production processes under GMP compliance.
• Knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
• Ability to work in, training for, or practical knowledge of clean room/aseptic environment operations
• Working knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports.
• Must be team-oriented (proactively build