Scientist, QC

Scientist I, 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 I, Quality Control will independently test, Raw Materials, pre-capsulation, Stability and Finished Products.  Analyze data, perform statistical analyses, document results, maintain laboratory notebook according to cGMP and Internal guidelines. The Scientist I, Quality Control will 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 SOPs 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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

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.

• Works flexible hours including weekends and evenings to accommodate the production / validation schedule.

• Other duties as assigned.

The Candidate

• Bachelor’s degree in science or related field required (Chemistry, Microbiology or Biology preferred).

• Five (5) + years’ experience in an analytical laboratory required.

• Must possess good interpersonal skills; Ability to effectively communicate with co-workers; good organizational skills.

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

• Vision requirements include ability to differentiate color, have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.

Why you should join Catalent: 

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment. 

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic, fast-paced work environment.

• Positive working environment focusing on continually improving processes to remain innovative.

• Potential for career growth on an expanding team within an organization dedicated