About the Company
Eurofins BioPharma Product Testing is a global leader in providing laboratory testing services for the pharmaceutical and biopharmaceutical industries. With a strong commitment to quality and regulatory compliance, we support clients from drug discovery through commercialization, ensuring the safety, efficacy, and quality of life-saving medicines. Our Overland Park facility plays a crucial role in our stability testing operations, contributing to critical long-term projects backed by stable industry demand and government-aligned research. Join a team dedicated to scientific excellence and making a real impact on public health.
Job Description
We are seeking a dedicated and meticulous Stability Chemist to join our team in Overland Park, KS. This role focuses on the execution and analysis of long-term stability studies for pharmaceutical products, ensuring compliance with cGMP regulations and ICH guidelines. The ideal candidate will have a strong background in analytical chemistry, excellent data interpretation skills, and a commitment to maintaining high standards of quality and scientific integrity. This position offers the opportunity to contribute to vital projects with stable government and industry backing, fostering professional growth within a supportive environment. You will be instrumental in ensuring product quality and shelf-life, working with cutting-edge instrumentation and a collaborative team.
Key Responsibilities
- Perform analytical testing on stability samples using techniques such as HPLC, GC, dissolution, KF, and pH.
- Execute long-term stability studies according to approved protocols and timelines.
- Document all experimental procedures, raw data, and results accurately and contemporaneously in lab notebooks and LIMS.
- Interpret and trend stability data, identifying out-of-specification (OOS) or out-of-trend (OOT) results and initiating investigations.
- Prepare comprehensive stability reports and present findings to project teams and clients.
- Ensure all work is conducted in strict compliance with cGMP, GLP, and ICH guidelines.
- Maintain and calibrate laboratory equipment, ensuring proper functionality and qualification.
- Contribute to the development and validation of analytical methods for stability testing.
- Collaborate effectively with cross-functional teams, including Quality Assurance, Manufacturing, and Project Management.
Required Skills
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
- 2+ years of experience in a cGMP pharmaceutical stability laboratory setting.
- Proficiency with analytical techniques including HPLC, GC, UV-Vis, KF, and dissolution testing.
- Strong understanding of ICH guidelines (Q1A, Q1B, Q1C, etc.) and cGMP regulations.
- Excellent data analysis, interpretation, and technical writing skills.
- Experience with LIMS (Laboratory Information Management System).
- Ability to work independently and as part of a team in a fast-paced, regulated environment.
- Meticulous attention to detail and strong organizational and time management skills.
Preferred Qualifications
- Master's degree in a relevant scientific discipline.
- Experience with Empower 3 chromatography data system or similar software.
- Knowledge of statistical analysis software for stability trending and shelf-life determination.
- Experience participating in regulatory audits (e.g., FDA, EMA).
- Proven track record of method development and validation in a pharmaceutical context.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance options.
- 401(k) retirement plan with competitive company match.
- Generous paid time off (PTO) and company holidays.
- Life and disability insurance coverage.
- Employee assistance program (EAP) for personal and professional support.
- Opportunities for professional development, training, and career advancement within a global organization.
- Stable work environment with involvement in long-term, impactful projects.
- On-site fitness center access or wellness programs (where available).
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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