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

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