JOB TITLE: Analytical Scientist- Catalent Pharma Solutions, Winchester, KY, US
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
The Analytical Scientist is responsible for performing analytical method research and development for raw materials, in-process samples and drug products in the Quality Control Department. Analytical Scientists work on method transfer, method verification and method validation under appropriate guidance in support of clinical development and commercial manufacturing. The candidate will work closely with the product development and process transfer teams to provide analytical results and proper data interpretation for drug product development and process validation. When necessary, the Analytical Scientist will conduct routine analytical testing for raw materials, in-process samples, drug products and cleaning verification in support of commercial product manufacturing.
- Demonstrate solid knowledge in both the theoretical and practical aspects of analytical chemistry, especially quantitative analysis.
- Develop and maintain working knowledge of commonly used spectroscopic, chromatographic and wet chemistry procedures.
- Work with various analytical methods including cleaning verification, assay and impurities, dissolution, residual solvents for raw materials, in-process samples or finished products testing.
- Understand and conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP, etc.).
- Prepare and review technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, analytical investigations, etc. for review.
- Understand drug product formulations, manufacturing process and work closely with product development and process transfer teams on testing of product development and process validation batches and providing proper data interpretation as necessary.
- Provide training to QC analysts after methods are validated/transferred/verified.
- When necessary, perform routine quality control testing for raw materials, in-process samples and finished product for commercial manufacturing operations.
- Ph.D, or M.S. in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry).Work Experience – 0 to 3 years of pharmaceutical industry experience, 3-5 years of analytical testing/research experience using HPLC/GC/UV, etc.B.S. in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Chemistry)Work Experience – At least 5 years pharmaceutical industry or 8 years of analytical testing/research experience using HPLC/GC/UV, etc.
- Works cross-functionally and receives exposure to several departments
- Medical, Dental, Vision and 401K are all offered from day one of employment
- 19 days of paid time off annually + 7 paid holidays
Leadership Competencies for Performance and Development
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.