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Veterans Preferred - Associate Scientist 2, Analytical Research & Development - 2nd Shift

Company: Catalent
Location: Saint Petersburg
Posted on: November 17, 2021

Job Description:

Military Veterans are Encouraged to Apply. Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Associate Scientist 2, Analytical Research & Development - 2nd Shift

**This is 2nd Shift, Monday thru Friday 3pm - 11:30pm**

St. Petersburg is our primary Softgel 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 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.

The Associate Scientist II, AR&D will independently test Raw Materials by both compendial and non-compendial methods with support of additional activities related to the testing of pre-capsulation, Stability and Finished Products as required. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. 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.

If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you!

The Role

  • Perform Compendial and non-compendial testing on Raw Materials and Drug Substances.
  • Performs assay/CU/dissolution and other single analyte chromatographic testing. Required to work with potent and teratogenic compounds with proper PPE equipment.
  • Prepares reagents, standards, media and mobile phase as needed for analyses.
  • 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.
  • Supports Material Evaluation Process for new materials. Shares responsibility for the routine calibration of analytical equipment such as, but not limited to balances, pH meters, KF analyzers, AA, IR, etc.
  • Provides project support for new product development programs under the direction of the lead scientist or group leader.
  • Assist with laboratory investigations using the appropriate Root Cause Analysis tools. Identifies/implements improvements that will reduce cycle time for testing/release products.
  • Works flexible hours including weekends and evenings to accommodate the production / validation schedule.
  • 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
    • Must possess good interpersonal skills; Ability to effectively communicate with co-workers; Good organizational skills required.
    • Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions.
    • Experience with U.V. spectroscopy, IR and AA instrumentation, H.P.L.C. and G.C. instrumentation and dissolution testing a plus.

      Why you should join Catalent
      • Cross functional exposure to other areas of Operations
      • Medical, Dental, Vision and 401K are all offered from day one of employment
      • 152 hours of paid time off annually + 8 paid Holidays

        We will identify candidates based on the following Catalent Competencies
        • Leads with Integrity and Respect
        • Delivers Results
        • Demonstrates Business Acumen
        • Fosters Collaboration and Teamwork
        • Champions Change
        • Engages and Inspires
        • Coaches and Develops

          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 customersand 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 to explore career opportunities.

          C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 . 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 for us to investigate with local authorities.

Keywords: Catalent, St. Petersburg , Veterans Preferred - Associate Scientist 2, Analytical Research & Development - 2nd Shift, Other , Saint Petersburg, Florida

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