Manufacturing Associate (Upstream & Downstream)
Job Title: Manufacturing Associate (Upstream & Downstream)
Location: Princeton Area, New Jersey
Hours / Schedule: Full-time, shift flexibility required (day, evening, overnight rotation possible, overtime available based on production needs)
Type: Temp-to-Hire (potential direct opportunity for the right fit)
SUMMARY
Support both Upstream and Downstream manufacturing operations in a cGMP-compliant environment. This role provides hands-on experience throughout the biologics production process — from cell culture to protein purification.
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, or related field
- 1–5 years of GMP experience in Pharmaceuticals, Biologics, Medical Devices, Cleanroom, or Chemical Processing environments
- Comfortable working in sterile/cleanroom settings and following strict protocols
- Strong interest in cross-functional manufacturing roles with growth potential
- Open to flexible hours outside of a standard 8am–5pm schedule
- Open to Temp-to-Hire employment
- Ability to stand for long periods and lift up to 50 lb
- Strong attention to detail and documentation skills
- Willingness to cross-train and support evolving production needs
Upstream
- Familiarity with aseptic techniques and bioreactor operation
- Experience with cell culture, buffer / media prep
- Understanding of chromatography, TFF (Tangential Flow Filtration), viral filtration
- Hands-on experience in cleanroom/purification operations
Upstream Manufacturing
- Prepare media and buffers
- Thaw vials, expand seed trains, and operate bioreactors (fed-batch/perfusion)
- Monitor/document cell growth and bioreactor parameters
- Support cell harvest through clarification and filtration
- Conduct chromatography operations (AKTA or similar systems)
- Perform Tangential Flow Filtration (TFF) and diafiltration
- Execute viral filtration procedures
- Support cleanroom-based final fill operations
- Adhere to cleanroom, gowning, and aseptic protocols
- Maintain GMP-compliant documentation
- Clean and sanitize production equipment
- Collaborate with Quality, Engineering, and Logistics teams
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