Scientist I, Quality Control

Scientist I, Quality Control

Position Summary

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year.  Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

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. 

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.

The Scientist I, Quality Control will independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. Analyze data, perform statistical analyses, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. 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. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. The Scientist I, Quality Control will maintain proper records in accordance with all SOP's and policies.

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

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 and identify bacteria or other microorganisms isolated on selective and non-selective media.

• Maintains cultures according to ATCC and departmental Standard Operating Procedures.

• Performs identification of microorganisms using techniques such as API, Gram Stain, etc.

• Prepares reagents, standards, medias, etc. needed for analysis.

• Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks.

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

• Other duties as assigned.

The Candidate

• Requires BA or BS with college course work in related sciences.

• At least 5 years' experience in an analytical laboratory.

• Must possess good interpersonal skills.

• Good organizational skills required.

• Experience with U.V. spectroscopy, IR, AA instrumentation, H.P.L.C. and G.C. instrumentation experience.

• Autoclave and Vitek.

• Experience in dissolution testing.

• Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.

• Knowledge of safety and hazardous waste requirements, data acquisition applications, databases, conducting and writing laboratory investigations.

• Ability to work effectively under pressure to meet deadlines.

• Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.

• Be accessible to manufacturing, laboratory and office staff. 

• Can use 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 l