Associate I, Manufacturing

Catalent Pharma Solutions•Glen Burnie, MD

1d•$26 - $31•Onsite

About The Position

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. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. We have an opportunity for an Associate I, Manufacturing to join our team and support upstream or downstream production operations. You will perform and document cGMP activities, operate process equipment, and execute validation protocols. The role includes creating and revising cGMP documents and completing assignments as directed. This position requires presence on the manufacturing floor, with shift and weekend work as part of the schedule.

Requirements

High School Diploma with 2+ years of GMP manufacturing experience, OR Associate’s Degree in a scientific, engineering, or biotechnology discipline with 1+ years of related GMP manufacturing experience, OR Bachelor’s Degree in a scientific or engineering discipline with basic knowledge of current Good Manufacturing Practices (cGMP) and relevant safety procedures.
Understanding of GMP manufacturing processes and the functional areas that support production, including Quality Control, Quality Assurance, Regulatory Affairs, and Materials Management.
Strong teamwork, collaboration, and communication skills, with the ability to work effectively in a fast-paced manufacturing environment.
Fluent in English with effective written and verbal communication abilities.
Ability to work assigned shifts, including weekends and overtime as needed to support manufacturing operations.
Capable of performing physical requirements of the role, including lifting up to 40 pounds and extended periods of standing, walking, bending, reaching, pushing, and pulling on the manufacturing floor.

Responsibilities

Execute cGMP manufacturing processes and support activities in accordance with batch records, SOPs, and established production procedures.
Accurately complete and maintain manufacturing documentation, equipment records, and production data in compliance with Good Documentation Practices (GDP).
Weigh, dispense, label, stage, and transfer raw materials and components to support manufacturing operations.
Prepare, filter, and transfer media and buffer solutions according to approved manufacturing procedures.
Operate production equipment such as pH meters, conductivity meters, osmometers, pumps, tubing welders, and filter integrity testers.
Perform basic equipment setup, operation, cleaning, sanitization, and troubleshooting within assigned manufacturing areas.
Assemble, disassemble, sterilize, and maintain manufacturing equipment, components, and process systems.
Support validation activities, deviations, change controls, and other compliance-related tasks in accordance with cGMP requirements.
Maintain production rooms, equipment logbooks, cleaning records, and inventory of manufacturing and sanitation supplies.
Participate in training programs and continuously develop proficiency in manufacturing operations, equipment, and compliance standards.
Perform other duties as assigned