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:

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.

Responsibilities:

• 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.

Requirements:

• 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.
• 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.

Salary Range: $84,000 - $105,000

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.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.