Manufacturing Associate (Upstream & Downstream)

System One
Pennington, NJ

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
Downstream
  • Understanding of chromatography, TFF (Tangential Flow Filtration), viral filtration
  • Hands-on experience in cleanroom/purification operations
RESPONSIBILITIES



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
Downstream Manufacturing
  • Conduct chromatography operations (AKTA or similar systems)
  • Perform Tangential Flow Filtration (TFF) and diafiltration
  • Execute viral filtration procedures
  • Support cleanroom-based final fill operations
General Duties
  • Adhere to cleanroom, gowning, and aseptic protocols
  • Maintain GMP-compliant documentation
  • Clean and sanitize production equipment
  • Collaborate with Quality, Engineering, and Logistics teams
#M3

Ref: #558-Scientific

Posted 2025-11-14

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