Catalent
Senior Microbiologist Scientist, Quality Control
Catalent, St. Petersburg, Florida, United States, 33739
Overview
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Senior Scientist, Quality Control
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Catalent . 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 supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with thousands of scientists and technicians and 40+ global sites. Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This is a full-time, on-site position at our St. Petersburg, FL location. The Senior Scientist, Quality Control will independently test, develop and implement assays useful for identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. The role involves data analysis, statistical analysis, documentation, and communication of results. Responsibilities include writing protocols, procedures and technical reports, keeping current with literature, training junior colleagues, and contributing to continuous improvement. Compliance with FDA, EPA and OSHA regulations and proper record-keeping according to SOPs and policies is required. We are 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
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 applicable protocols, methods and compendials. Cultivates and identifies bacteria or other microorganisms on selective and non-selective media; maintains cultures according to ATCC and SOPs. Performs identification of microorganisms using techniques such as API and Gram Stain. Prepares reagents, standards, media, etc. needed for analysis. Works with potent and teratogenic compounds. Disposes of hazardous waste per environmental regulations and procedures. Audits analyst’s and technician’s calculations in notebooks/logbooks and verifies results in reports and/or LIMS for accuracy and data integrity. 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. Performs analysis of non-routine products and develops or modifies analytical testing procedures as needed. Works flexible hours including weekends and evenings to accommodate production/validation schedule. Acts 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 of experience in an analytical laboratory. Good interpersonal skills. Ability to sit, stand, walk regularly and lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Vision requirements include ability to differentiate color, 20/30 vision with or without corrective lenses, and ability to read documents and use a computer monitor. Ability to work extended hours or off-hours as required. Why You Should Join Catalent
Tuition Reimbursement – help pursue further education. WellHub program to promote 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 process. Diverse, inclusive culture with Employee Resource Groups focusing on D&I, community engagement and green initiatives. Dynamic, fast-paced work environment with emphasis on process improvement and innovation. Potential for career growth within an expanding team. Perkspot – exclusive discounts from a wide network of merchants. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by emailing DisabilityAccommodations@catalent.com with job number, title and location. Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted without a signed search agreement will not be considered. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates for payments or highly sensitive information during the offer process. If you receive anything suspicious, forward to spam@catalent.com for investigation.
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Join to apply for the
Senior Scientist, Quality Control
role at
Catalent . 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 supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with thousands of scientists and technicians and 40+ global sites. Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. This is a full-time, on-site position at our St. Petersburg, FL location. The Senior Scientist, Quality Control will independently test, develop and implement assays useful for identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. The role involves data analysis, statistical analysis, documentation, and communication of results. Responsibilities include writing protocols, procedures and technical reports, keeping current with literature, training junior colleagues, and contributing to continuous improvement. Compliance with FDA, EPA and OSHA regulations and proper record-keeping according to SOPs and policies is required. We are 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
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 applicable protocols, methods and compendials. Cultivates and identifies bacteria or other microorganisms on selective and non-selective media; maintains cultures according to ATCC and SOPs. Performs identification of microorganisms using techniques such as API and Gram Stain. Prepares reagents, standards, media, etc. needed for analysis. Works with potent and teratogenic compounds. Disposes of hazardous waste per environmental regulations and procedures. Audits analyst’s and technician’s calculations in notebooks/logbooks and verifies results in reports and/or LIMS for accuracy and data integrity. 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. Performs analysis of non-routine products and develops or modifies analytical testing procedures as needed. Works flexible hours including weekends and evenings to accommodate production/validation schedule. Acts 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 of experience in an analytical laboratory. Good interpersonal skills. Ability to sit, stand, walk regularly and lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Vision requirements include ability to differentiate color, 20/30 vision with or without corrective lenses, and ability to read documents and use a computer monitor. Ability to work extended hours or off-hours as required. Why You Should Join Catalent
Tuition Reimbursement – help pursue further education. WellHub program to promote 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 process. Diverse, inclusive culture with Employee Resource Groups focusing on D&I, community engagement and green initiatives. Dynamic, fast-paced work environment with emphasis on process improvement and innovation. Potential for career growth within an expanding team. Perkspot – exclusive discounts from a wide network of merchants. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by emailing DisabilityAccommodations@catalent.com with job number, title and location. Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted without a signed search agreement will not be considered. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates for payments or highly sensitive information during the offer process. If you receive anything suspicious, forward to spam@catalent.com for investigation.
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