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Chemical/Biochemical Engineer

Company: Eurofins Lancaster Laboratories
Location: Framingham
Posted on: January 22, 2023

Job Description:

Job Description

  • Manage and oversee analytical activities performed in-house and at contract sites associated with method development, qualification/validation, transfer and drug product qualification for production and quality specifications.
  • Calibrate and operate BGA (Rapid lab 1260), ViCell, Nova Flex 1, Nova Flex2, Bio HT and advanced Osmometer equipment.
  • Apply advanced scientific principles and concepts to a broad range of research problems and develop innovative analytical solutions related to drug products in compliance with appropriate SOPs and regulatory guidelines.
  • Monitor and report progress of project deliverables within agreed project timelines.
  • Coordinate with other groups and activities necessary to ensure deliverables are met.
  • Assure all laboratory documentation and other regulatory compliance systems are maintained according to regulatory standards.
  • Author/review and edit key documents such as SOPs for analytical test methods, study protocols, reports, training materials, relevant sections of regulatory filings and deficiency requirements and responses.
  • Develop and revise documents with suitable terminology, content and format to ensure compliance with site guidelines on analytical equipment.
  • Maintain control of documentation, including accurate document history and change revision.
  • Periodically review SOPs, forms and other GMP-related documents and facilitate Corrective and Preventative Actions (CAPA).
  • Maintain QMS trainings to ensure regulatory compliance and in according to internal SOPs.
    Qualifications
    The Ideal Candidate Possesses:
    • Experience with analytical methodologies to characterize drug substances for raw materials, in-process and finished products.
    • Experience in calibrating and operating BGA (Rapid lab 1260), ViCell, Nova Flex 1, Nova Flex 2, Bio HT and advanced Osmometer equipment.
    • Ability to adapt to shifting priorities, change, stressors and to find appropriate balance between needs of the organization, others and self
      Minimum Qualifications
      • BS in Chemical/Biochemical Engineering/Biological Sciences or related discipline with 3 - 4 years' relevant industry experience in upstream process development or MS + 1 - 2 years' experience.
      • Prior analytical experience.
      • Ability to effectively proofread documents to ensure accuracy.
      • Active listening skills. Ability to translate verbal guidance into precise operating instructions on analytical equipment.
      • Strong organizational and communication skills.
      • Team based collaborative problem solving.
      • Strong understanding of cGMP, Data Integrity and ALCOA principles.
      • Authorization to work in the United States indefinitely without restriction or sponsorship.
        Additional Information
        Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Framingham, MA are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
        • Life and disability insurance
        • 401(k) with company match
        • Paid vacation and holidays
          Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins Lancaster Laboratories, Framingham , Chemical/Biochemical Engineer, Engineering , Framingham, Massachusetts

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