Process Development Data Reviewer/Senior Research Associate (Biotechnology)

Location: 4117 Emperor Blvd, Durham, North Carolina, United States

Company

hirify.global provides contract process development and related services for biologics, including monoclonal antibodies, recombinant proteins, and peptides.

What you will do

• Review data for process development programs, process characterization projects, and material supply campaigns.
• Verify that calculations and documented information are correct, complete, accurate, and compliant with internal procedures and guidance.
• Review raw data transcription, manual calculations, laboratory notebooks, batch records, and final reports.
• Document observations, add comments and edits, and communicate required corrections to document stakeholders.
• Route documents for additional review and ensure corrections are completed accurately and on time.

Requirements

• Bachelor’s degree or equivalent in Biotechnology or a related field plus 4 years of relevant experience, or a Master’s degree or equivalent plus 2 years of relevant experience.
• Experience with laboratory execution and data verification in the biotechnology industry.
• Experience using statistical software for data analysis.
• Knowledge of GDP, GMP, and regulations for biotechnology-derived products.
• Experience with electronic document management systems, laboratory notebooks, and batch records.
• Ability to communicate review results in non-technical language with document stakeholders.

Culture & Benefits

• Full-time employment with a 40-hour workweek.
• Equal opportunity and affirmative action employer committed to workforce diversity.