Upstream Scientist - Large Scale Development Operations

Job Description

The Upstream Process Development Scientist is responsible for the development, optimization, characterization, and scale-up of upstream bioprocesses supporting the production of biologics, vaccines, cell therapies, or other biotechnology products. This role applies scientific expertise in cell culture, media development, process monitoring, and bioreactor operations, utilizing 50L, 250L, and 500L single-use bioreactor systems to improve process performance, product quality, and manufacturing efficiency. The scientist collaborates closely with cross-functional teams, including Process Development, Manufacturing, Analytical Sciences, and Quality, to support technology transfer, process validation, and commercial manufacturing activities. This role may also contribute to continuous improvement initiatives, troubleshooting efforts, and the implementation of innovative bioprocess technologies to enable successful large-scale biopharmaceutical manufacturing.

• Design, develop, optimize, and scale upstream bioprocesses, including mammalian cell culture, and bioreactor operations, to support research, clinical, and commercial manufacturing objectives.

• Plan and execute process development studies to improve cell growth, productivity, product quality, and overall process robustness using sound scientific and engineering principles.

• Analyze experimental data, and identify critical process parameters to support process understanding, scale-up, and technology transfer activities.

• Collaborate with cross-functional teams, including Manufacturing, Analytical Sciences, Quality, and Process Engineering, to advance development programs and support manufacturing operations.

• Author and review study protocols, technical reports, process descriptions, regulatory documentation, and standard operating procedures (SOPs) in compliance with applicable quality standards.

• Troubleshoot process deviations and technical challenges, implement corrective actions, and support continuous improvement initiatives to enhance process performance and operational efficiency.

• Foster a collaborative, engaged, and team-oriented work environment.

• May also perform smaller studies from the 10L down to Shake Flask range.

Qualifications

• Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or related scientific discipline.

• Familiar with cell passaging including vial thaw, inoculation and harvest processes for 50L, 250L, and 500L single-use bioreactors.

• Authorization to work in the United States indefinitely without restrictions or sponsorship

Preferred Experience

• Certified Biomanufacturing Professional (CBP)

• Lean Six Sigma Green Belt or Black Belt

• GMP or Bioprocess Manufacturing Training Certification

• Proficient with recording data via eLNs, following SOPs and validation reports.

• Familiar with GMP and GLP standards.

Additional Information

This position is Full-Time, Monday - Friday, 8:00 a.m. - 5:00 p.m . Candidates currently living within a commutable distance of Spring House, PA are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.