Process Development Scientist

We are seeking an Upstream/Downstream Scientist to support process development activities within a biotechnology/biopharmaceutical environment. The ideal candidate will have experience in scientific data verification, technical documentation, process development, and working in a GMP-regulated environment. This role requires strong technical writing skills, attention to detail, and the ability to review scientific reports and laboratory documentation.

Required Qualifications (Must Have)

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

Preferred Qualifications (Nice to Have)

• Experience with Upstream Process Development (Cell Culture/Bioreactor).
• Experience with Downstream Process Development (Purification).
• Process Characterization experience.
• Process Performance Qualification (PPQ) experience.
• Experience supporting late-stage biologics commercialization.
• Experience with Pre-License Inspection (PLI) readiness.
• Experience using Lab Key.
• Technical Transfer experience.
• Knowledge of quality agreement documentation.