Senior Process Development Data Reviewer | Biotech

KBI Biopharma, Inc.; Durham (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Process Development Data Reviewer/Senior Research Associate to perform meticulous data review for contract services projects, ensuring calculations and documentation are correct and compliant with guidance and internal procedures.

This role targets monoclonal antibodies, recombinant proteins, and other biologics. You will add comments, route documents for review, and collaborate with stakeholders to resolve data issues.

Qualifications

• Review transcription of raw data into records and final reports.
• Data analysis using statistical software.
• GDP, GMP, and biotechnology regulations knowledge.
• Experience with electronic document management systems.
• Experience with laboratory notebooks and batch records.

Responsibilities

• Perform data review for process development projects ensuring accuracy and compliance.
• Add comments and edits to documents to identify incomplete data.
• Route documents for additional review and corrections as needed.
• Verify calculations and documentation are complete and correct.
• Communicate results to stakeholders in non-technical language.
• Support data integrity under GMP/GDP guidelines.

Skills

Data review

Data verification

Data analysis

Scientific writing

Communication

Electronic document management

Lab notebooks

Education

Bachelor’s degree in Biotechnology

Master’s degree in Biotechnology or related field

Tools

Statistical software

LIMS

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Process Development Data Reviewer/Senior Research Associate to perform meticulous data review for contract services projects, ensuring calculations and documentation are correct and compliant with guidance and internal procedures.

This role targets monoclonal antibodies, recombinant proteins, and other biologics. You will add comments, route documents for review, and collaborate with stakeholders to resolve data issues.