Downstream Technical Writing Scientist

Key Responsibilities

• Review, verify, and maintain scientific data and technical documentation.
• Prepare and edit technical reports, laboratory records, and process development documents.
• Support downstream process development activities, including purification processes.
• Ensure documentation complies with GMP requirements and data integrity standards.
• Review Electronic Laboratory Notebook (ELN) records for accuracy and completeness.
• Collaborate with cross-functional teams to support process characterization, PPQ, technology transfer, and PLI readiness activities.

Required Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline.
• 3+ years of process development experience in the biotechnology or biopharmaceutical industry.
• Experience with Downstream Process Development (Purification).
• Technical writing and scientific documentation experience.
• Experience reviewing technical reports and laboratory documentation.
• Scientific data verification experience.
• GMP environment experience and familiarity with ELN systems.
• Excellent written and verbal communication skills.