Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.
Job Summary
What you'll do
- Perform advanced chemical and analytical testing on raw materials, in-process samples, and finished products.
- Execute a variety of laboratory techniques, including pH, conductivity, HPLC, GC, FTIR, titration, and other analytical methods.
- Draft and review laboratory documentation such as analytical data, technical reports, SOPs, investigations, and change controls.
- Review data packages for release, stability, and in-process testing to support material disposition.
- Conduct statistical analysis of data, including trending and hypothesis testing.
- Support validation activities including method, equipment, and software IOQ/PQ initiativesc.
- Develop and review protocols and reports for validation studies, assay development, and method transfers.
- Operate, maintain, and troubleshoot laboratory instruments and resolve analytical issues.
- Support internal and external audits to ensure compliance with regulatory and company requirements.
- Ensure adherence to safety procedures, including proper handling and disposal of hazardous materials.
- Assist with laboratory operations such as inventory management, equipment calibration, and housekeeping.
- Collaborate cross-functionally and communicate effectively with team members and stakeholders.
- Train and mentor junior staff while modeling company values and professional standards.
- Contribute to continuous improvement initiatives and support CAPAs, deviations, and change control processes.
Qualifications and need-to-know
- Bachelor’s Degree in Chemistry or Biological Sciences.
- Minimum of 5 years of related laboratory experience in the pharmaceutical industry, or equivalent combination of education and experience.
- Experience performing chemical assays and analytical testing.
- Experience with method development, validation, and laboratory instrumentation.
- Strong knowledge of USP/EP compendia.
- Working knowledge of cGMP, FDA, and regulatory requirements.
- Proficiency in Microsoft Office Suite.
- Strong written, verbal communication, and organizational skills.
- Preferred: Experience with TrackWise, computer system validation (ISPE GAMP), and Lean Six Sigma tools.
Pay Range: $77,000.00-$116,000.00
Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.
Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.
Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:
- Medical, vision and dental insurance
- Life and AD&D insurance
- Paid holidays
- PTO accrual
- and much more!
Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!
If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com.
Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.