QC Scientist II

Position Summary:

Join a high-impact, GMP testing analytical team as a member of the Quality Control (QC) Analytical department. Modalities include monoclonal antibodies, peptides, and other recombinant proteins. This position leads: Contract Testing Laboratory (CTL) management, extensive cross-functional communications, the implementation of control charts, the compilation of testing for batch release, and authorship of certificates and laboratory investigations in a contract manufacturing facility.

Additionally, this individual will be a subject matter expert (SME) in the sampling, release testing, and management of the aforementioned produced biologics to support the daily activities involved in compliant testing, training, and audit readiness. This individual must be able to interface effectively with management personnel and SMEs across analytical, manufacturing, engineering, and quality teams.

Must have a strong biochemistry background in biopharmaceutical analytical testing and understand cGMP standards and requirements. Must have excellent critical thinking and troubleshooting skills, the ability to analyze, interpret, and present complex data with conclusions and understanding of impact to the product. This role requires excellent writing skills with full grasp of grammar, spelling and style rules, and compliance with quality standard guidelines and factual accuracy.

Responsibilities include:
• Product Testing: In-process and release testing as assigned; techniques include (but not limited to) HPLC, SDS-CGE, ELISA, qPCR, SoloVPE, and compendial testing per USP
• Solution preparation
• Analysis and collation of data to draw conclusions
• Trend analysis using control charting
• Drafting method transfer protocols
• Drafting method transfer reports
• Execution of method transfer, method qualification, and/or method validation testing under protocol
• Independently authors or reviews lab investigation and deviation reports
• Develops and/or owns and implements Corrective and Preventive Actions
• Tracks and/or implements department metrics; actively engages in improvement of department metrics
• Ensures state of safety and regulatory audit readiness at all times
• Participates in data review activities, as needed
• Ensures Trainer qualification status to expand team matrix
• Laboratory support
• It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory/facility

Position Requirements:
Knowledge, Skills, Abilities
For QC Scientist II position: B.S. degree and 8+ years of related experience; M.S. degree and 6+ years of related experience; Ph.D. in a specific discipline and 2+ years of related experience. Able to react to change productively and handle other essential tasks as assigned. Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.

Language Ability
Able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Reasoning Ability
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Math Ability
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Posting range: $101,000.00 / yr - $138,000.00 / yr

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.