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Associate Scientist II, Analytical Research & Development - Saint Petersburg Florida
Company: Disability Solutions Location: Saint Petersburg, Florida
Posted On: 04/25/2024
Associate Scientist II, Analytical Research & DevelopmentPosition Summary--Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. ---Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.--The Analytical Research and Development (AR&D) laboratory that supports evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples.-- AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials.-- The department provides analytical services to manufacturing, process development, validation and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings.-- Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg's Quality departmental policies.Once trained, the Associate Scientist II will independently test raw materials to both compendial and non-compendial methods.-- Once trained, the Associate Scientist II independently test pre-capsulation, stability and finished product samples as per established methods.-- Analyze data, document results, maintain laboratory notebook according to cGMP and internal SOPs.-- Communicate results in written and oral presentation as needed.-- Help in writing procedures, specifications and test methods.-- Keep abreast of literature in field; help train 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.-----The Role---- - Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and Perform compendial and non-compendial testing on raw materials, drug substances, in-process samples, cleaning samples and finished products as required.--
- Performs assay/CU/dissolution and other single analyte chromatographic testing.
- Prepares reagents, standards, media and mobile phase as needed for analyses.
- Required to work with potent and teratogenic compounds with proper PPE equipment.--
- Disposal of hazardous waste according to environmental regulations and company procedures.
- Tabulation/ interpretation of results of analysis as recorded in notebooks, reports and logbooks.
- Assures right-first-time execution of departmental methods and SOPs.
- Writes/ reviews analytical methods, deviations, protocols, SOPs and other technical documents.
- Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, etc.--
- Other duties as assigned.--The Candidate----
- AS in science with 10 plus years in an analytical lab, 5 in GMP environment, or BS in science with 3 plus years in an GMP analytical lab.
- Expertise in wet chemistry techniques such as titrations, extractions as per compendia.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds.
- Working with potential hazards will require wearing proper personal protective equipment.Why You Should Join Catalent--
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