Upstream/Downstream Scientist

United Pharma Technologies Inc • Contract • Washington, United States, US • 13h ago

Job Title: Upstream/Downstream Process Development Scientist

Location: Seattle, WA

Job Summary

We are seeking an experienced Upstream/Downstream Process Development Scientist to support biologics process development activities for a leading biotechnology organization. The ideal candidate will have hands-on experience in upstream and/or downstream process development, scientific data review, technical documentation, and GMP-compliant laboratory operations. This role requires strong analytical skills, attention to detail, and experience supporting late-stage biologics development and commercialization.

Key Responsibilities

Support upstream (cell culture/bioreactor) and/or downstream (purification) process development activities for biologics.
Review and verify scientific data, laboratory notebooks, and technical reports for accuracy, completeness, and compliance.
Prepare and review technical documentation, protocols, reports, and development summaries.
Maintain accurate documentation within Electronic Laboratory Notebook (ELN) systems.
Ensure all activities comply with GMP regulations and internal quality standards.
Collaborate with Process Development, MSAT, Manufacturing, Analytical Development, and Quality teams.
Support process characterization, technology transfer, and Process Performance Qualification (PPQ) activities.
Assist with Pre-License Inspection (PLI) readiness and regulatory documentation, as required.
Identify data discrepancies and drive timely resolution through cross-functional collaboration.

Required Qualifications

Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline.
Experience in Process Development within the biotechnology or biopharmaceutical industry.
Strong experience reviewing scientific data, laboratory documentation, and technical reports.
Technical writing experience within a regulated GMP environment.
Experience using Electronic Laboratory Notebook (ELN) systems.
Excellent attention to detail with the ability to identify inconsistencies in scientific data.
Strong written and verbal communication skills.