Data Reviewer/Scientist I

Name of Employer: KBI Biopharma, Inc.

Position Title: Data Reviewer/Scientist 1

Position Location: 1101 Hamlin Road, Durham, NC 27704

Days / Hours: Mon - Fri / 9:00 a.m. - 5:00 p.m.

Summary of Duties: Perform data review for contract services projects, including GMP testing for internal and external manufacturing and stability studies, as well as analytical and formulation development programs for monoclonal antibodies, proteins, and peptides. Data review for assay categories: Particle Analysis, Spectrophotometry, Gel Analysis, Plate Based Assay, Binding Assay, HPLC, Trace Analysis, Capillary Electrophoresis, Biophysical Techniques, Method Qualification and Validation. Maintain knowledge of instrumentation and GMP standards. Employ data review software (Empower, 32 Karat, Softmax, Compass, Chemidoc). Verify that calculations, electronic data, and documented information are compliant and accurate. Make detailed observations and report documentation corrections as needed. Demonstrate strong communication and ability to work independently and as part of a team.

Qualifications: Bachelor's degree or equivalent in Biology, Chemistry or related field of study and 6 years of progressive experience in analytical data review in a pharmaceutical setting. Employer will accept a Master's degree or equivalent in Biology, Chemistry or related field of study and 4 years of experience in analytical data review in a pharmaceutical setting, in lieu of Bachelor's degree or equivalent and 6 years of progressive experience.

Applicants must have demonstrated experience with:

• 3 years of experience following cGMP documentation practices;
• 3 years of experience working with formulas, scientific equations, and graphs; 3 years of experience in analytical software, including Empower , SoftMax, or Compass;
• 3 years of experience with GMP testing, stability studies, analytical and formulation development of monoclonal antibodies, proteins, or peptides;
• 3 years of experience within a pharmaceutical setting completing weekly analytical data review assignments in cGMP environment and independently handling Method Qualification and Method Validation reviews; and
• 3 years of experience with Biopharmaceutical regulatory agency (FDA/EMA) inspection readiness for data integrity ALCOA+ and 21 CFR part 11 regulatory compliance requirements in cGMP environment.

Any and all experience may be gained concurrently.

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 is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.