The Analytical Scientist reports to the Associate Director of Quality Control.
Due to growth, Catalent is looking to recruit an Analytical Scientist to join our growing Quality Control group at our site in Winchester, KY.
The Analytical Scientist will 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.
Catalent's Winchester location is the flagship US manufacturing location for large-scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.
Demonstrate strong skills/expertise/high proficiency on two or more specific analytical techniques. For instance troubleshooting of HPLC or GC instrumental problems, dissolution methods, or related substance assays. High throughput, based on the level of difficulty, in areas of proficiency, is expected.
Develop and maintain a 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.
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.
Ability to perform analytical method research and development.
Strong working experience with chromatographic (e.g., HPLC or GC) and spectroscopic (e.g., UV) analysis in candidate’s research work.
Understand analytical chemistry calculations such as concentrations (%, ppm, µg/mL, etc), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.
Understand solubility, oxidation/reduction, acid/base hydrolysis, heat, and photodegradation.
Works cross-functionally and receives exposure to several departments
The potential for career growth within an expanding QC team as well as other areas
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
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied. ™ Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Internal Number: 0029001
About Catalent Pharma Solutions
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.
Catalent. More products. Better treatments. Reliably supplied. ™