Senior Microbiologist Scientist, Quality Control

Senior 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 and analytical services to solve your most difficult development and manufacturing challenges.

The Senior 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. The Senior Scientist, Quality Control will 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. Maintain proper records in accordance with all SOP's and policies. 

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. 

This is a full-time, on-site salary position at our St. Petersburg, FL location.

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. 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, media, etc. needed for analysis. Works with potent and teratogenic compounds. Disposes of hazardous waste according to environmental regulations and company/departmental procedures
• 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
• Releases samples (LIMS) to Quality Assurance for product disposition. Manages new product, method and technology transfers
• Perform analysis of non-routine products. Develops new analytical testing procedures or modifies existing test procedures.
• Works flexible hours including weekends and evenings to accommodate the production / validation schedule.
• Performs as the Group Leader’s Designee in the absence of the Group Leader.
• All other duties as assigned.

The Candidate:

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
• 8+ years experience in an analytical laboratory.
• Must possess good interpersonal skills.
• 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, have 20/30 vision wit