Senior Scientist, Analytical Research & Development

Position Summary
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.
The AR&D laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, process development, validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.
The Senior Scientist, Analytical Research & Development will Independently develop, validate, and routinely execute test methods in support of Drug Substances and Drug Products as required. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. The Senior Scientist, Analytical Research & Developmentcommunicates results in written and oral presentations and will help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Role

• Lead all analytical method transfer activities as required by their area. Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document. Facilitates and supports activities and services necessary to the routine operations of the department, as assigned.
• Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
• Ability to independently develop and validate instrumental methods in support of Drug Substances and Drug products.
• Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences.
• Ability to make autonomous decisions regarding day-to-day activities.
• Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
• Preparation of reagents/standards/medias needed for analysis according to established methods. Safe handling of potent and teratogenic compounds. Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
• Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks. Capable of self-scheduling of work assignments. Assures right-first-time execution of departmental methods and SOPs. Perform other duties as required.

The Candidate

• Requires a minimum of: Doctorate in scientific field with 3 years' experience in lab, 2 in GMP; or MS in scientific field with 5+ years' experience in lab, 3 in GMP, or a BS in scientific field with 10 years' experience in lab, 8 in GMP.
• Minimum of 5 years' experience with identification or separation techniques such as HPLC, UPLC, GC, MS, NMR and experience with method development and or validation.
• Experience with drug development and regulatory requirements for submissions.
• Experience with common pharmaceutical laboratory equipment including, but not limited to, U.V. spectroscopy, IR and AA instrumentation, H.P.L.C. and G.C. instrumentation - ICP-MS or ICP-OES instrumentation, Dissolution testing.
• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
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