Associate Scientist II, QC

Associate Scientist II, 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 Associate Scientist II, 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, document results, maintain laboratory notebook according to cGMP and Internal guidelines, communicate results in written and oral presentations, help in writing Procedures, Specifications and Test Methods. The Associate Scientist II, Quality Control will 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 and maintain 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

This position is 100% on-site at the St. Petersburg site.

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

•  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.

• 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 Specifications, protocols, Methods and Compendial monograms.

• Prepare reagents, standards, Medias, etc. needed for analysis.

• May be required to work with potent and teratogenic compounds. Capable of working under moderate supervision.

• Helps receive, label and store receipts of solvents and analytical reagents.

• Verifies co-workers’ calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.

• Logs results into GLIMS database.

• Perform other duties as assigned.

The Candidate

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

• Analytical laboratory experience preferred.

• Experience with common pharmaceutical laboratory equipment including but not limited to, HPLC, U.V spectroscopy, IR, AA and G.C instrumentation, Autoclave, Vitek, dissolution testing, etc.

• 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 earn a new one!

• WellHub program