Manufacturing Associate (Downstream)
Job Title: Manufacturing Associate (Upstream & Downstream)
Location: Pennington, New Jersey
Type: Contract
Compensation: $25.00–$32.00 per hour
Contractor Work Model: Onsite
Hours: 40.0 hours per week
Responsibilities
- Support both Upstream and Downstream manufacturing operations in a cGMP-compliant environment
- Assist with preparing media and buffers for cell culture processes
- Thaw vials, expand seed trains, and operate bioreactors (fed-batch/perfusion)
- Monitor and document cell growth, environmental conditions, and bioreactor parameters
- Support cell harvest via clarification and filtration
- Conduct chromatography operations (AKTA or similar systems)
- Perform Tangential Flow Filtration (TFF) and diafiltration operations
- Execute viral filtration procedures under GMP guidelines
- Support final fill operations in a cleanroom environment
- Follow all cleanroom, gowning, and aseptic protocols strictly
- Maintain accurate, GMP-compliant documentation
- Clean and sanitize production equipment and environments
- Collaborate with Quality, Engineering, and Logistics teams
Requirements
- High School Diploma or Associate’s Degree with 1–5 years of relevant GMP experience OR Bachelor’s Degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering,
- GMP Manufacturing experience in Pharmaceuticals, Medical Devices, Biologics, Cleanroom environments, or Chemical Processing
- Experience with cell culture operations, buffer/media preparation (preferred)
- Basic knowledge of chromatography, TFF, and viral filtration (preferred)
- Understanding of aseptic technique and familiarity with bioreactors (preferred)
- Ability to stand for long periods and lift up to 50 lbs
- Strong attention to detail, documentation skills, and ability to follow SOPs precisely
- Willingness to support flexible hours, including support outside of standard 8 am–5 pm schedule
- Excellent communication skills and adaptability to changing production needs
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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