Associate III, Manufacturing

Catalent•Harmans, MD

5d•Onsite

About The Position

We have an opportunity for an Associate III, Manufacturing to join our team and support upstream production operations. In this role, you will perform and document cGMP activities, operate process equipment, and assist with validation protocols. You will also create and revise cGMP documents while ensuring compliance with regulatory standards. This position offers the chance to contribute to process optimization and efficiency improvements in a dynamic manufacturing environment.

Requirements

Bachelor's or Master’s degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field with a minimum of 4 years of related experience, OR High School diploma or Associate’s degree in a technical discipline with a minimum of 5 years of related experience.
Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks.
Focus on safe behaviors and ability to recognize unsafe conditions.
Thorough understanding of quality systems in a regulated environment and commitment to right first time (RFT) execution.
Excellent documentation skills including comprehension, review, and preparation of Batch Production Records, SOPs, deviation, and summary reports.
Team-oriented and proactive in building healthy working relationships.
Actively pursues learning of required and new skills, and new equipment.
Proficient understanding of equipment function and application.
Proficient in MS Office and related PC skills.
Ability to work a set shift with occasional overtime as required.
Extended periods of walking, standing, bending, reaching, pushing, and pulling.

Nice To Haves

Experience supporting bacterial fermentation operations, including upstream processing, bioreactor monitoring, and cGMP-compliant manufacturing practices.

Responsibilities

Collaborate with Manufacturing Science & Technology (MS&T), Development, Engineering, and Quality teams to support technology transfer, process scale-up, equipment implementation, and continuous improvement initiatives.
Lead designated upstream manufacturing operations and provide technical guidance to support production objectives.
Operate bioreactors and execute aseptic cell culture, fermentation, and fill-finish manufacturing processes in accordance with GMP requirements.
Monitor and execute critical manufacturing processes, ensuring adherence to batch records, SOPs, quality standards, and regulatory requirements.
Prepare, weigh, dispense, label, and stage raw materials, media, and buffer solutions for manufacturing operations.
Perform product transfers, filtration, sampling, environmental monitoring coordination, and routine process documentation to support production activities.
Operate, maintain, clean, sterilize, and troubleshoot manufacturing equipment, including bioreactors, centrifuges, autoclaves, washers, and laboratory instrumentation.
Support equipment maintenance, calibration, validation activities, corrective and preventive actions (CAPAs), and process improvement initiatives.
Author, review, and revise manufacturing documentation, including SOPs, batch records, training materials, protocols, and reports while ensuring data integrity and compliance.
Train and mentor manufacturing personnel on technical operations, scientific principles, safety practices, and GMP requirements while supporting cross-functional teams to achieve production goals.
Perform other duties as assigned.