Associate Scientist I

Associate Scientist I Position Summary Once trained, independently test raw materials to both compendial and non-compendial methods. Once trained, 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. Assist in updating procedures and test methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA, cGMP and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies. The Analytical Research and Development (AR&D) laboratory 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. Monday-Friday 8 AM-5 PM The Role Support analytical scientists to complete milestones for development programs Perform compendial and non-compendial testing on drug substances, in-process samples, cleaning samples and finished products as required. Prepares chemistry 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 of results of analysis as recorded in notebooks, reports, and logbooks. Assures right-first-time execution of departmental methods and SOPs. Supports activities and services necessary to the operations of the department, as assigned. Shares responsibility for the routine calibration / standardization of analytical equipment such as, but not limited to balances, pH meters, KF titrators, AA, IR, UV/VIS, etc. Other duties as assigned. The Candidate Associate in Science (AS) degree in scientific field with 5 years in an analytical GMP laboratory or Bachelor of Science (BS) in a scientific field. Experience with common analytical laboratory equipment: UV/VIS, IR, AA, and Dissolution. Knowledge of wet chemistry techniques such as titrations and extractions as per compendia Knowledge of laboratory safety and hazardous waste requirements Good organizational skills required. Why You Should Join Catalent Several Employee Resource Groups focusing on D&I Employee Stock Purchase Program Tuition Reimbursement – Let us help you finish your degree or earn a new one! Generous 401K match 19 days accrued PTO 8 paid holidays 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. Catalent = Catalyst Talent Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us! personal initiative. dynamic pace. meaningful work. Catalent is the perfect place to grow your career if… You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT). You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world! You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people. You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first. You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU! See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

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