Job Description

Associate III, Manufacturing

About Site

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.

Position Summary

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.

Shift: Day Shift - 7am-7pm on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite

The Role

• 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.

The Candidate
Minimum 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.

Preferred Skills & Background

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

Pay

The anticipated hourly rate for this position in MD is $38.46 - $43.26 Plus Bonus. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.