Job Summary:

Perform data review for commercial program documents including Process Performance Verification (PPQ) reports, Continuous Process Verification (CPV report) and any other reports supporting process validation 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.

Job Responsibilities (Approximate % of Time):

• Performs timely and critical review of manufacturing and analytical data to ensure all data, calculations, and documented information are present, complete, accurate, and compliant. (60%)
• Adds comments and edits to applicable documents to identify incomplete/inaccurate data and other errors. Routes documents for additional review and corrections as needed. Ensures corrections are completed accurately. (20%)
• Photocopies, transcribes, and archives required documents, as appropriate. (5%)
• As needed, provide technical writing support for protocol and summary report technical documents. (10%)
• Reacts to change productively and handles other essential tasks as assigned. (5%)

Job Requirements:

1.1 Knowledge, Skills, Abilities

Minimum requirement is a Bachelor of Science degree in a scientific discipline with experience with data review and/or Manufacturing/Lab experience. (B.S. and 3+ years of experience or M.S. and 1+ years of experience).

Must have knowledge of GMPs and biotechnology-derived product regulations.

Also requires a demonstrated track record in the following key areas:

• Strong orientation for quality and customer service
• Demonstrated level of respect for individuals
• High level of integrity and personal responsibility
• Strong collaboration and team building skills

1.2 Language Ability

Ability to read and interpret English documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to communicate with coworkers and supervisors.

1.3 Reasoning Ability

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

1.4 Math Ability

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute ratio and percent.

1.5 Physical Demands

See Essential Physical Functions table.

1.6 Computer Skills

MS Teams, Outlook, Word, Excel, and PowerPoint. Familiarity with Unicorn, JMP or other statistical software is a plus.

1.7 Equipment Use

Computer, telephone, lab equipment

Working Conditions:

May require work outside of normal business hours to support critical regulatory deliverables or client interactions.

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.