Scientist, QC

Scientist, Quality Control

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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 Scientist, Quality Control will independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. In addition, this role will Analyze data, perform statistical analyses, document results, maintain laboratory notebook according to cGMP and Internal guidelines. The Scientist, Quality Control will also write protocols, procedures and technical reports, keep abreast of literature in field, attend meetings, help train junior colleagues, contribute to continuous improvement within the group and comply with FDA, EPA and OSHA regulations, performing all work in a safe manner while maintaining proper records in accordance with all SOP's and policies.

Shifts: Monday -Friday, 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch

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

• Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective protocols, Methods and Compendials.

• Cultivate & identify bacteria or other microorganisms isolated on selective & non-selective media.

• Audits analyst's and technician's calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems (LIMS) to check for accuracy and integrity of data.

• Supervises and schedules work assignments for analytical chemists and technicians.

• Performs other miscellaneous duties as required.

• May assist in providing guidance/training to new and existing personnel.

• Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis

• Perform other duties as assigned.

The Candidate

• Bachelor of Arts or Bachelor of Science with college course work in related sciences is required.

• 5+ years’ experience in an analytical laboratory is preferred.

• Must possess good interpersonal skills.

• Ability to effectively communicate with co-workers.

• Good organizational skills required.

• Experience or familiarity with instruments and techniques including UV spectroscopy, IR and AA instrumentation, HPLC and GC, dissolution testing, wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.

• Knowledge of safety and hazardous waste requirements and data acquisition applications and databases.

• Experience in conducting and writing laboratory investigations.

• Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds; no lifting greater than 40.09 pounds without assistance.

• Be accessible to the manufacturing floor and office staff and use the required office equipment.

• 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.

Why You Should Join Catalent

• Tuition Reimbursement – Let us help you finish your degree or