Scientist, Quality Control

About Site St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated. About Site St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated. Position Summary We have an opportunity for a Scientist, Quality Control to join our team. In this role, you will perform microbiological and analytical testing of finished products, raw materials, and validation samples. You will also conduct environmental and utility testing, maintain microbial cultures, and prepare necessary reagents and materials. This position involves interpreting and documenting results, supporting laboratory equipment activities, and ensuring compliance with GMP and safety requirements. Shift: Standard Hours, Monday through Friday Location: St. Petersburg, FL 100% Onsite The Role Perform microbiological and analytical testing of finished products, raw materials, in-process materials, and validation samples according to approved methods, protocols, and compendia. Conduct environmental and utility testing, including water, compressed gases, manufacturing environments, moisture, and cleaning/process validation support. Cultivate, isolate, and identify microorganisms using selective and non-selective media, Gram staining, API, and other identification techniques. Maintain microbial cultures in accordance with ATCC requirements and departmental Standard Operating Procedures. Prepare reagents, standards, media, and other materials required for laboratory testing. Interpret, document, and enter analytical results into approved notebooks, reports, logbooks, and the LIMS database. Support laboratory equipment activities, including qualification (Installation Qualification/Operational Qualification/Performance Qualification), training, preventive maintenance, calibration, troubleshooting, and repairs. Follow Good Manufacturing Practices, safety, regulatory, and environmental requirements, including hazardous/DEA waste handling and working with potent or teratogenic compounds; serve as Senior Scientist Designee when needed. Other duties as assigned. The Candidate Minimum Requirements Bachelor of Arts or Bachelor of Science with college coursework in related sciences. 5+ years of experience in an analytical laboratory. Good interpersonal skills. Ability to effectively communicate with co-workers. Strong organizational skills. Experience with Infrared and Atomic Absorption instrumentation. High-Performance Liquid Chromatography and Gas Chromatography instrumentation experience. Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing, laboratory, and office staff. Ability to 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 lenses. For Catalent's in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles. Ability to work extended hours or off-hours as required. Preferred Skills & Background Experience with Ultraviolet spectroscopy. Experience with Infrared and Atomic Absorption instrumentation. High-Performance Liquid Chromatography and Gas Chromatography instrumentation experience. Experience with autoclave. Why You Should Join Catalent Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Competitive Paid Time Off plus 8 paid holidays. Medical, dental, and vision benefits effective day one of employment. Tuition Reimbursement – support to finish your degree or earn a new one. Employee Resource Groups focusing on Diversity and Inclusion. Environmentally friendly, community engagement green initiatives including regularly participating in Beach Clean-up. Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. WellHub program to promote overall physical and mental wellness. Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. 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 sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities. #J-18808-Ljbffr