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Manager Analytical - Swiftwater, PA

Company: Sanofi
Location: Swiftwater
Posted on: September 24, 2022

Job Description:

POSITION OVERVIEW

This position will be in the Analytical Support Section of the Quality Control Department to support the department's goals. The main activities of the role are as follows:

  • Method validation (Wet chemistry, instrument, biological)
  • Method transfers (Wet chemistry, instrument, biological)
  • Method development and/or optimization
  • Improvement projects
  • New product support for test methods
  • Statistical support (Basic statistical abilities)
  • Compendial compliance
  • General QC troubleshooting and support.


    Main responsibility will be to support the assay lifecycle program which includes method validation, method transfer, method development, change controls, investigations, and general method troubleshooting and support. There is an opportunity for exposure and the ability to work on a variety of test method techniques in addition to HPLC.

    This role is for the QC Analytical Support Group which interacts with many internal and external groups including QC, Manufacturing Technology, Research and Development, Clinical Group, Regulatory Affairs, Operations, Government Health Authorities, External Testing Labs, and the FDA.

    This is not a people manager position.

    KEY RESPONSIBILITIES:
    • General Method development, method transfer, and method validation.


      KEY ACTIVITIES:
      • Participate in project teams involved in the method transfer/validation of QC Analytical Methods
      • Author and Review documents in support of the department functions
      • Represent the QC Department during FDA and Health Authority audits as a Subject matter Expert for HPLC and QC Methods
      • Ability to manage multiple projects and work independently on assigned tasks as an individual contributor and in teams
      • Experience and the ability to perform basic statistical analysis as assigned for expiry dating, trend analysis, OOT, OOS, and troubleshooting of QC test methods
      • Perform laboratory tasks in strict compliance with local documents and Federal Regulations including data integrity
      • Provide support to QC groups to support test methods and projects


        BASIC QUALIFICATIONS:
        • BS Degree in Chemistry or related field with 3 -5 years experience in a cGMP environment with experience method validation.


          Technical Competencies
          • Excellent organizational, written, interpersonal, and teamwork abilities
          • W orking knowledge of cGMPs


            Other Skills
            • Multi-tasking (will be assigned multiple projects)
            • Detail Oriented
            • Interpersonal communication and collaboration across multiple groups and cultures
            • Independent Work


              As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

              According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

              Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

              #GD-SP

              #LI-SP

              At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Sanofi, Scranton , Manager Analytical - Swiftwater, PA, Executive , Swiftwater, Pennsylvania

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