Upstream Scientist - Large Scale Development Operations

Eurofins USA PSS Insourcing Solutions•Spring House, PA

About The Position

The Upstream Process Development Scientist develops, optimizes, characterizes, and scales upstream bioprocesses that support production of biologics, vaccines, cell therapies, and other biotechnology products. The role applies expertise in cell culture, media development, process monitoring, and bioreactor operations, using 50L, 250L, and 500L single-use bioreactor systems to improve process performance, product quality, and manufacturing efficiency. Smaller studies may also be performed from 10L down to shake-flask scale. The scientist works with Process Development, Manufacturing, Analytical Sciences, Quality, and other cross-functional teams to support technology transfer, process validation, and commercial manufacturing. The role may also contribute to troubleshooting, continuous improvement, and the implementation of bioprocess technologies for large-scale biopharmaceutical manufacturing.

Requirements

Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
Familiarity with cell passaging, including vial thaw, inoculation, and harvest processes for 50L, 250L, and 500L single-use bioreactors.
Authorization to work indefinitely in the United States without restrictions or sponsorship.

Nice To Haves

Certified Biomanufacturing Professional (CBP).
Lean Six Sigma Green Belt or Black Belt.
GMP or Bioprocess Manufacturing Training Certification.
Proficiency recording data via electronic laboratory notebooks (eLNs) and following SOPs and validation reports.
Familiarity with GMP and GLP standards.

Responsibilities

Design, develop, optimize, and scale upstream bioprocesses, including mammalian cell culture and bioreactor operations, for research, clinical, and commercial manufacturing.
Plan and execute process development studies to improve cell growth, productivity, product quality, and process robustness.
Analyze experimental data and identify critical process parameters to support process understanding, scale-up, and technology transfer.
Collaborate with Manufacturing, Analytical Sciences, Quality, Process Engineering, and other cross-functional teams to advance development programs and support manufacturing operations.
Author and review study protocols, technical reports, process descriptions, regulatory documentation, and standard operating procedures in compliance with applicable quality standards.
Troubleshoot process deviations and technical challenges, implement corrective actions, and support continuous improvement initiatives.
Contribute to a collaborative, engaged, and team-oriented work environment.
Perform smaller studies from 10L down to shake-flask scale as needed.