NAME OF EMPLOYER: KBI Biopharma, Inc.
POSITION TITLE: 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: Bachelors 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 Masters 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 Bachelors 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.
2) Data analysis using statistical software.
3) GDP, GMP, and biotechnology-derived product regulations.
4) Communicating and discussing review results in a non-technical language with document stakeholders.
5) Electronic document management systems.
6) Laboratory notebooks and batch records.
CONTACT: If interested please apply online at https://www.kbibiopharma.com/careers with R00008788.
