Upstream Manufacturing Associate

Job Description

Job Description

Job Title: Upstream Manufacturing Associate

Position Summary

The Upstream Manufacturing Associate supports GMP-compliant upstream bioprocessing activities within a CDMO environment. This role is responsible for executing cell culture operations, bioreactor runs, and associated documentation to support clinical and commercial manufacturing programs. The ideal candidate has hands-on upstream manufacturing experience, a strong understanding of GMPs, and the ability to work across multiple client programs in a fast-paced, regulated environment.

Key Responsibilities

Upstream Manufacturing Operations

• Execute GMP upstream manufacturing activities including:
• • Mammalian cell culture expansion and maintenance
  • Seed train operations
  • Operation of single-use and/or stainless-steel bioreactors
  • Media and buffer preparation
• Perform inoculation, feeding, sampling, monitoring, and harvest operations
• Operate process equipment (bioreactors, incubators, centrifuges, mixers, filtration systems)
• Perform in-process sampling and basic testing (e.g., cell counts, viability, metabolite analysis)

Documentation & Compliance

• Accurately complete GMP documentation including batch records, logbooks, and electronic systems
• Follow standard operating procedures (SOPs), batch production records (BPRs), and work instructions
• Support deviation investigations, CAPAs, and change controls as needed
• Participate in internal and client audits and regulatory inspections

Process Support & Continuous Improvement

• Identify and escalate process deviations or equipment issues
• Support technology transfer, process characterization, and scale-up activities
• Assist with troubleshooting manufacturing issues and implementing process improvements
• Contribute to 5S, lean manufacturing, and continuous improvement initiatives

Training & Collaboration

• Train and mentor junior manufacturing associates as assigned
• Collaborate cross-functionally with Quality, MSAT, Facilities, and Supply Chain teams
• Support multi-client manufacturing schedules typical of a CDMO environment

Required Qualifications

• Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Biology, or a related scientific field
• Minimum of 3 years of hands-on upstream GMP manufacturing experience in a biotech, pharmaceutical, or CDMO environment
• Experience with mammalian cell culture and bioreactor operations
• Working knowledge of cGMP regulations and documentation practices
• Ability to work in cleanroom environments and follow aseptic techniques
• Strong attention to detail and ability to follow complex procedures

Preferred Qualifications

• Experience in a CDMO or multi-product manufacturing environment
• Experience with single-use bioreactor systems (e.g., Sartorius, Cytiva, Thermo Fisher)
• Familiarity with MES, electronic batch records, and data integrity requirements
• Experience supporting clinical and/or commercial manufacturing campaigns

Physical & Schedule Requirements

• Ability to work shifts, weekends, or extended hours as required by manufacturing schedules
• Ability to lift up to [X] lbs and perform repetitive tasks while wearing appropriate PPE
• Ability to work in controlled cleanroom environments for extended periods

Core Competencies

• GMP compliance and quality mindset
• Team-oriented and collaborative approach
• Strong communication and documentation skills
• Adaptability in a fast-paced, client-driven environment