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Veterans Preferred - Analytical Development Associate IV

Company: Catalent
Location: Chelsea
Posted on: November 12, 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

Job Title

Analytical Development Associate IV

Position Summary

The Analytical Development Associate IV is responsible for performing analytical chemistry research and/or development in collaboration with others to develop assays based on new and existing methodologies.

This role will be located at our site in Chelsea, MA.

This 90,000 square-foot Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

The Role (daily responsibilities)

  • Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
  • Statistically and critically analyzes data to support drug candidate and analytical method development and validation.
  • Summaries method development and validation activities into regulatory filing appropriate documentation.
  • Participates in Laboratory and/or Quality Investigations as relating to analytical methodologies.
  • Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
  • Participates in the construction and/or revision of Analytical Test Methods.
  • Assists in the writing and updating of analytical test procedures.
  • Responsible for identifying, alerting and proposing solutions to issues on instruments and/or test executions; leads and implements recommended solutions and/or corrective actions.
  • Independently organizes work flows to accomplish objectives, provides guidance and support to colleagues as needed, promotes new policies and programs tactfully and authentically, and may author/document performance reviews and/or evaluations
  • Other duties as assigned

    The Candidate (requirements)
    • Bachelor's Degree in Analytical Chemistry (or similar) required.
    • Minimum of 5-8 years of experience with analytical method development, analytical method transfer and/or analytical method validation activities
    • Experience working in a cGMP regulated environment preferred.
    • Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.
    • Extensive experience with executing a variety of analytical test methods, preparing protocols that comply with statistical randomization principles (i.e. DOE), auditing data, troubleshooting instrumentation, trending data and statistical analyses required.
    • Demonstrated ability to lead projects and/or teams independently.
    • Extensive experience with analytical method development and validation.
    • Demonstrated ability to lead and evaluate analytical methods as potential root causes for supporting cGMP investigations.
    • Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.
    • Familiarity with executing Standard Operating Procedures in a GMP setting preferred.
    • Chromatography skills using Empower and/or ChemStation required.
    • Critical understanding of the importance of documentation and data traceability required.

      Why you should join Catalent:
      • Competitive medical benefits and 401k
      • 19 days of PTO + 8 paid holidays
      • State of the art equipment and facility
      • Ample growth opportunities

        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 www.catalent.com/careers 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 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.

Keywords: Catalent, Chelsea , Veterans Preferred - Analytical Development Associate IV, Other , Chelsea, Massachusetts

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