Manufacturing Associate II

Catalent•Harmans, MD

1d•$34 - $38•Onsite

About The Position

The Associate II, Manufacturing supports GMP upstream or downstream manufacturing processes for bulk biologics produced using microbial and cell culture systems. The role applies scientific knowledge to operational and routine tasks for Phase I/II and commercial GMP manufacturing and contributes to compliance and operational excellence. It reports to the Supervisor, Manufacturing. The position is based at Catalent’s Harmans/BWI campus in Harmans, Maryland, and is 100% onsite. The stated schedule is a day shift from 7 a.m. to 7 p.m. on a 2-2-3 rotation. The campus supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral-vector therapies and vaccines.

Requirements

One of the following education and experience combinations: high school diploma or GED and at least 4 years of GMP-compliant upstream or downstream biologic production experience; an associate degree in a scientific, engineering, or biotech field and at least 2 years of such experience; or a bachelor's degree in one of those fields and at least 1 year of such experience.
Upstream experience may include fermentation or bioreactor processes; downstream experience may include column chromatography or buffer/media skids.
Strong knowledge of scientific principles and ability to apply them to operational and routine production tasks.
Excellent documentation skills, including comprehension, review, and preparation 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 required by production needs.
Ability to meet the physical requirements of the role, 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 focusing 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 the 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 available theories and proven approaches.
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 persons-in-plant 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.