Process Development Data Reviewer Senior Research Associate

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 with R.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma Inc. to hire me. If I am hired I understand that either KBI Biopharma Inc. or I can terminate my employment at any time and for any reason with or without cause and without prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.