JOB DESCRIPTION

USP GMP Scientist/ Biotechnologist

Position summary

The USP GMP Biotechnologist performs hands-on upstream manufacturing activities for mammalian or microbial cell culture processes in a GMP-regulated CDMO environment. The role is primarily responsible for safe, compliant, and timely execution of seed train, bioreactor, harvest, equipment preparation, cleaning, and documentation activities. Strong practical GMP manufacturing experience is essential. Experience supporting cell line generation or cell line development is beneficial but is not required.

Position responsibilities

• Execute upstream GMP manufacturing operations according to approved batch records, SOPs, work instructions, and production schedules.

• Perform cell culture operations, including cell thaw, shake-flask expansion, seed train execution, inoculation, bioreactor operation, sampling, monitoring, and harvest.

• Prepare media, feeds, buffers, reagents, and process solutions; complete required calculations, labels, status controls, and documentation.

• Set up, operate, clean, and perform routine checks of upstream equipment such as biosafety cabinets, incubators, cell counters, pumps, balances, single-use bioreactors, controllers, and harvest systems.

• Perform aseptic manipulations and closed or functionally closed processing using qualified techniques in controlled GMP areas.

• Complete batch records, logbooks, forms, and electronic records accurately and contemporaneously in accordance with GDP and ALCOA+ principles.

• Perform equipment and room preparation, line clearance, material staging, component verification, cleaning, disinfection, and post-operation closeout.

• Follow gowning, environmental monitoring, contamination-control, biosafety, waste-handling, and controlled-area behavior requirements.

• Monitor critical process parameters and cell culture performance, including viable cell density, viability, metabolites, pH, dissolved oxygen, temperature, agitation, gas flow, and process alarms.

• Immediately escalate deviations, atypical observations, equipment issues, contamination risks, and documentation errors; support investigations and CAPA implementation as assigned.

• Support material inventory, consumable readiness, equipment status tracking, and GMP suite scheduling to maintain manufacturing readiness.

• Participate in shift handoffs, daily production meetings, pre-run readiness reviews, and cross-functional coordination with Manufacturing, QA, QC, MS&T/Process Development, Facilities, and Warehouse teams.

• Support technology transfer, engineering runs, process qualification, and continuous-improvement activities under appropriate guidance.

• Assist with training of new personnel after qualification and demonstrate consistent adherence to safety, quality, and data-integrity expectations.

• When business needs require, support non-GMP upstream or cell line development activities such as routine cell culture, transfection support, clone handling, screening, or cell banking.

Position requirements

• BS in Biotechnology, Biology, Biochemistry, Biochemical/Chemical Engineering, or a related discipline.

• Typically 6+ years of hands-on biopharmaceutical manufacturing experience, including at least 2 year working directly in a GMP-regulated manufacturing environment. Equivalent combinations of education and experience may be considered.

• Demonstrated experience executing GMP batch records and SOPs, including contemporaneous documentation, corrections, review, and adherence to Good Documentation Practices.

• Hands-on experience with cell culture and upstream operations such as seed train expansion, shake flasks, bioreactors, sampling, process monitoring, and harvest.

• Working knowledge of aseptic technique, contamination control, gowning, controlled-area behavior, and safe handling of biological materials.

• Experience preparing media, buffers, feeds, and process solutions using controlled recipes and verified calculations.

• Ability to recognize process or equipment abnormalities, respond appropriately, and escalate issues promptly.

• Ability to work accurately in a fast-paced CDMO environment where client timelines, quality commitments, and operational priorities may change.

• Ability to work effectively in cross-functional teams and communicate clearly during shift handoffs and manufacturing escalations.

• Ability to lift and move materials up to 40 lb (18 kg), stand for extended periods, perform repetitive manipulations, and work in cleanroom garments, subject to applicable accommodation requirements.

• Availability to support flexible schedules, including early starts, evenings, weekends, holidays, or on-call coverage as manufacturing campaigns require.

Preferred qualifications

• Experience in a multi-product CDMO or clinical/commercial biologics manufacturing environment.

• Experience with single-use bioreactor systems and associated controllers, tubing assemblies, sterile connectors, pumps, and in-process analytical equipment.

• Experience supporting deviations, investigations, CAPAs, change controls, equipment qualification, or process validation activities.

• Familiarity with electronic batch records, manufacturing execution systems, LIMS, or electronic document-management systems.

• Experience with cell line generation or cell line development activities, including transfection, clone screening, cell banking, or cell line characterization. This experience is preferred but not required.

Core competencies

• GMP discipline and strong attention to detail

• Aseptic execution and contamination-control mindset

• Reliable batch-record and data-integrity practices

• Technical learning agility and practical troubleshooting

• Clear communication, teamwork, and accountability

• Safety focus and consistent procedural compliance

Working environment

The position involves work in laboratory and GMP manufacturing environments with biological materials, cleaning and disinfecting agents, process equipment, controlled access, and cleanroom gowning requirements. Work may be performed across multiple shifts to support manufacturing campaigns and client commitments.

Role emphasis

Primary requirement: hands-on GMP upstream manufacturing experience and reliable execution in a regulated environment. Nice to have: cell line generation or broader CLD experience.