Position Summary:
Reviews data associated with method verifications/validations/ qualifications of microbiological methods and testing of in-process and drug substance/product samples. Ensures high quality assessment of tests and investigations, timely review and release of results and maintenance of the electronic environmental monitoring program. Assists with trending of Environmental Monitoring data.
Position Responsibilities:
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Reviews data and reports associated with development and qualification of microbiological methods and testing of in-process and drug substance/ drug product samples.
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Verifies that calculations and documented information is present complete and accurate.
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Verifies that all analyses are performed per methodology and are in compliance with GMP requirements, when applicable.
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Understands assays used to develop methods and/or test samples.
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Trains on Microbiology/ES assays and is able to perform assays when needed.
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Responsible for developing a current understanding of cGMP and other regulatory requirements.
Minimum Requirements:
B.S. degree and 8 years of related experience; M.S degree and 6 years of related experience; or Ph.D. in a related discipline. Able to react to change productively and handle other essential tasks as assigned. Adheres to all safety requirements.
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.
KBI Biopharma Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about KBI Biopharma and has not been reviewed or approved by KBI Biopharma.
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Healthcare Strength — Health coverage includes medical, dental, and vision with HSA/FSA options, alongside life and disability insurance. Employer-verified listings indicate solid foundational coverage across sites.
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Leave & Time Off Breadth — PTO and paid holidays are provided, with flexible or “unlimited” PTO available in some salaried roles and standard accrual with limited rollover elsewhere. This breadth supports time away options across job families.
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Parental & Family Support — Parental leave is available, with indications of 12 weeks for U.S. employees in recent materials. Maternity and paternity leave are included as part of the package.
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What We Do
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. KBI is proud to be a JSR Life Sciences Company.
