Associate I, Manufacturing

Catalent; Harmans (MD); On-site; USD 36,000 - 43,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Career development

Paid time off

8 paid holidays

Job summary

Catalent's Harmans, MD facility is seeking an Associate I, Manufacturing to support upstream or downstream production. You will perform cGMP activities, operate process equipment, and help create and revise manufacturing documents on the floor, including weekend shifts on a 2-2-3 schedule.

This onsite role requires a high school diploma with GMP experience or a science/engineering degree plus GMP exposure, ability to lift up to 40 pounds, and strong teamwork and English communication on a

Qualifications

• GMP manufacturing experience and understanding of validated processes.
• Ability to interpret batch records and SOPs in a GMP setting.
• Team coordination and clear written/verbal communication.
• Flexibility to work nights, weekends, and overtime.

Responsibilities

• Execute cGMP manufacturing processes and support activities per batch records and SOPs.
• Document, maintain, and verify equipment records and production data.
• Weigh, dispense, label, stage, and transfer raw materials for production.
• Prepare media/buffer solutions and operate process equipment.
• Set up, operate, clean, sanitize, and troubleshoot production equipment.
• Disassemble/assemble equipment and support validation/change control tasks.
• Maintain logs, inventory, and cleaning records for production rooms.
• Participate in training and continuous proficiency development.
• Perform other duties as assigned.

Skills

GMP manufacturing experience

Teamwork

Communication skills

Fluent English

Shift flexibility

Physical stamina

Education

High School Diploma or equivalent

Associate's Degree in science/engineering/biotech

Bachelor's Degree in science/engineering

Job description

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.

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 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.

Shift

Night shift, 7pm-7am on a 2-2-3 rotation

Location

Harmans, MD - BWI

Contract type

100% Onsite

The Role

• 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

The Candidate

Minimum 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.

Pay

The anticipated hourly rate for this position in MD is $26.44 – $31.25 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