Senior Microbiologist Scientist, Quality Control

Catalent • Saint Petersburg, FL

67d

About The Position

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.

Requirements

• 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 with or without corrective lenses, read written documents and frequent use of a computer monitor.
• Ability to work extended hours or off-hours as required.

Responsibilities

• 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.
• Maintain proper records in accordance with all SOP's and policies.
• Perform 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.
• Maintain cultures according to ATCC and departmental Standard Operating Procedures.
• Perform identification of microorganisms using techniques such as API, Gram Stain, etc.
• Prepare reagents, standards, media, etc. needed for analysis.
• Work with potent and teratogenic compounds.
• Dispose of hazardous waste according to environmental regulations and company/departmental procedures.
• Audit analyst's and technician's calculations in notebooks/logbooks and verify results in reports and/or appropriate systems (LIMS) to check for accuracy and integrity of data.
• Supervise and schedule work assignments for analytical chemists and technicians.
• Release samples (LIMS) to Quality Assurance for product disposition.
• Manage new product, method and technology transfers.
• Perform analysis of non-routine products.
• Develop new analytical testing procedures or modify existing test procedures.
• Work flexible hours including weekends and evenings to accommodate the production/validation schedule.
• Perform as the Group Leader's Designee in the absence of the Group Leader.
• All other duties as assigned.

Benefits

• 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 to preserving and bettering lives.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree