Downstream Manufacturing Associate

Job Description Job Description Job Title: Downstream 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 environment6b250ea6-cee3-481d-915c-f7283f1b2f1b