At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
Reviews data associated with development and qualification of biopharmaceutical assay methods and testing of in-process and drug substance/product biopharmaceutical protein samples.
Position Responsibilities:
Reviews data and reports associated with development and qualification of analytical methods and testing of in-process and drug substance/drug product samples.
Verifies that calculations and documented information are present, complete, and accurate.
Verifies that all analyses are performed per applicable standard operating procedures and test methods, and are in compliance with GMP requirements.
Understands experiments and biopharmaceutical assays used to develop methods and/or test samples. Maintains and updates knowledge of instrumentation.
Responsible for developing a current understanding of cGMP and other regulatory requirements.
Reacts to change productively and handle other essential tasks as assigned.
Minimum Requirements:
B.S. degree and 5-7 years of related experience. M.S. and 4-5 years of related experience.
Able to react to change productively and handle other essential tasks as assigned.
Salary: $74,000-$102,300
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting upon hire and employee recognition programs.
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.
Skills Required
- B.S. degree with 5-7 years related experience, or M.S. degree with 4-5 years related experience.
- Experience reviewing data and reports for analytical method development and qualification.
- Ability to verify calculations and ensure documentation is complete and accurate.
- Knowledge of and ability to follow applicable SOPs, test methods, and cGMP requirements.
- Understanding of biopharmaceutical experiments, assays, and laboratory instrumentation; ability to maintain/update instrumentation knowledge.
- Ability to react productively to change and handle assigned tasks.
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.
KBI Biopharma Insights
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.
