Process Development Data Reviewer/ Senior Research Associate

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

Process Development Data Reviewer/ Senior Research Associate

POSITION LOCATION: 4117 Emperor Blvd, Durham, NC 27703

HOURS: Full Time/40 hours

JOB DUTIES

Perform data review for contract services projects, including process development programs, process characterization projects and material supply campaigns for monoclonal antibodies, recombinant proteins, peptides and other biologics. This review includes the verification that calculations and documented information are correct, complete, and accurate in accordance with guidance documents and internal procedures. Make detailed observations and report documentation corrections to the relevant personnel, as needed. Perform timely and critical review of process development data to ensure all data, calculations, and documented information are present, complete, accurate, and compliant. Add comments and edits to applicable documents to identify incomplete/inaccurate data and other errors. Route documents for additional review and corrections as needed. Ensure corrections are completed accurately.

REQUIREMENTS

• Bachelor’s degree or equivalent in Biotechnology, or related field of study and 4 years of experience with lab execution, data verification in the biotechnology industry, or any combination thereof.
• Employer will accept a Master’s degree or equivalent in Biotechnology or related field of study and 2 years of lab execution, data verification in the biotechnology industry, or any combination thereof, in lieu of Bachelor’s degree or equivalent and 4 years of experience.
• Applicants must have demonstrated experience with: 1) Reviewing transcription of raw data into records and final reports, including data transformed by manual calculations.
• Data analysis using statistical software.
• GDP, GMP, and biotechnology-derived product regulations.
• Communicating and discussing review results in a non-technical language with document stakeholders.
• Electronic document management systems.
• Laboratory notebooks and batch records.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.