Manufacturing Associate II

Catalent Pharma Solutions•Glen Burnie, MD

1d•$34 - $38•Onsite

About The Position

The Associate II, Manufacturing supports GMP upstream or downstream manufacturing processes for bulk biologics made using microbial and cell culture systems. The role applies scientific knowledge to resolve operational and routine production tasks for Phase I/II and commercial GMP manufacturing, and contributes to compliance and operational excellence. The position reports to the Supervisor, Manufacturing and is based 100% onsite at Catalent’s Harmans/BWI campus in Harmans, Maryland. The shift is 7 a.m. to 7 p.m. on a 2-2-3 rotation. Catalent’s FDA-licensed CGMP gene therapy campus supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. The Harmans/BWI-1 facility includes CGMP manufacturing suites, fill/finish, central services, testing laboratories, and a warehouse. The Harmans/BWI-2 facility is under development and is planned to include additional CGMP manufacturing suites and cold storage warehousing.

Requirements

High school diploma or GED plus at least 4 years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance; or an associate degree in a scientific, engineering, or biotechnology field plus at least 2 years of such experience; or a bachelor’s degree in a scientific, engineering, or biotechnology field plus at least 1 year of such experience.
Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks.
Strong documentation skills, including comprehension, review, and establishment of Batch Production Records, Standard Operating Procedures, deviations, and summary reports.
Team-oriented approach and ability to collaborate across Manufacturing, Quality Control, Quality Assurance, Regulatory, and Materials Management.
Strong written and verbal communication skills and proficiency in English.
Ability to work flexible schedules, including shifts, overtime, and weekend coverage as production needs require.
Ability to perform physical requirements, including lifting up to 40 pounds and extended periods of standing, walking, bending, reaching, pushing, and pulling.
Ability to work safely and effectively in a manufacturing environment while maintaining a strong focus on quality, compliance, and operational excellence.

Responsibilities

Complete Batch Production Records in accordance with current Good Manufacturing Practices and document processes using Standard Operating Procedures and Batch Production Records.
Generate and revise operational protocols and internal or external documents, including Standard Operating Procedures, Batch Production Records, deviations, and summary reports.
Collaborate with Process Development and Manufacturing Sciences and Technology teams to transfer new projects into GMP manufacturing.
Support initiation and closure of deviations; may lead departmental investigations and close deviations and Corrective and Preventive Actions.
Troubleshoot process and equipment issues and work with Facilities and Validation to maintain manufacturing equipment.
Recommend equipment and supply purchases for production areas.
Develop solutions to operational problems using knowledge of available theories and proven solutions.
Work with production management on current and new manufacturing projects to develop processes and techniques that meet objectives and avoid delays.
Collaborate with various departments and assist other teams as needed.
Interact with clients during manufacturing campaigns and may oversee and escort person-in-plant visitors during campaigns.
Participate in facility expansion and equipment validation activities.
Maintain full training in GMP manufacturing operations and documentation while adhering to safety guidelines.
Perform other duties as assigned.