About the Company
Eurofins BioPharma Product Testing is a global leader in providing comprehensive laboratory testing services to the biopharmaceutical industry. With a commitment to scientific excellence and unparalleled quality, we support drug development and manufacturing through a wide range of analytical services, ensuring the safety, efficacy, and quality of life-saving medicines. Our Wichita facility is a key hub for innovation and advanced analytical method development.
Job Description
We are seeking a highly motivated and experienced Senior Analytical Scientist with a strong focus on method development to join our dynamic team in Wichita, KS. The successful candidate will play a critical role in designing, developing, and validating analytical methods for various biopharmaceutical products, supporting both research and routine testing. This position requires a deep understanding of analytical chemistry principles, extensive hands-on experience with advanced analytical instrumentation, and a proven track record in method development and troubleshooting. You will contribute to cutting-edge projects, mentor junior scientists, and collaborate cross-functionally to drive scientific innovation and achieve project goals.
Key Responsibilities
- Lead the design, development, optimization, and validation of analytical methods for biopharmaceutical products (e.g., proteins, antibodies, nucleic acids, small molecules) using a variety of techniques (HPLC, UPLC, GC, LC-MS, GC-MS, CE, Karl Fischer, dissolution, spectroscopy).
- Perform complex analytical testing, interpret data, troubleshoot issues, and provide scientific justifications for method performance and results.
- Author and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submissions.
- Mentor and train junior analytical scientists on method development principles, laboratory techniques, and data analysis.
- Collaborate with R&D, Quality Control, Manufacturing, and Regulatory Affairs teams to ensure successful project execution and compliance.
- Stay current with industry trends, regulatory guidelines (e.g., ICH, FDA, USP, EP), and new analytical technologies.
- Ensure all work is performed in compliance with cGMP, GLP, and company quality standards.
Required Skills
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 5+ years of relevant industry experience, or Master's degree with 8+ years, or Bachelor's degree with 10+ years of experience.
- Extensive hands-on experience in analytical method development, optimization, and validation for biopharmaceutical products.
- Proficiency with a wide range of analytical techniques, including HPLC, UPLC, GC, LC-MS, GC-MS, and spectroscopic methods (UV-Vis, FTIR).
- Strong understanding of cGMP/GLP regulations and ICH guidelines.
- Excellent problem-solving, data analysis, and critical thinking skills.
- Strong written and verbal communication skills with the ability to present complex scientific data effectively.
- Demonstrated ability to work independently and collaboratively in a fast-paced, multidisciplinary environment.
Preferred Qualifications
- Experience with method transfer and method remediation.
- Knowledge of statistical experimental design (DoE) for method development and validation.
- Experience with LIMS and electronic lab notebooks (ELN) systems.
- Prior experience in a contract research organization (CRO) or contract development and manufacturing organization (CDMO) setting.
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and company holidays.
- Life and disability insurance.
- Employee assistance program.
- Professional development and continuing education opportunities.
- Tuition reimbursement program.
- On-site fitness center and wellness programs (at select locations).
- Flexible spending accounts (FSA) and health savings accounts (HSA).
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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