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Quality Control Lab Manager

Company: CRISPR Therapeutics
Location: Framingham
Posted on: March 13, 2023

Job Description:

Company OverviewCRISPR Therapeutics -is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. -CRISPR Therapeutics -has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, -CRISPR Therapeutics -has established strategic partnerships with leading companies including -Bayer, Vertex Pharmaceuticals -and -ViaCyte, Inc. -CRISPR Therapeutics AG -is headquartered in -Zug, -Switzerland, with its wholly-owned -U.S. -subsidiary, -CRISPR Therapeutics, Inc., and R&D operations in -Boston, -Massachusetts -and -San Francisco, California, and business offices in -London, -United Kingdom.Position SummaryThe newly formed QC team is looking for an eager individual to manage the quality control function to support manufacture and release testing, data integrity, and sample management programs at our brand-new state-of-the-art facility in Framingham, MA. This role, supporting the internal QC operations at CRISPR, is a highly visible position that will support the implementation of the Laboratory Information Management System (LIMS) as well as to construct, exercise, and continuously improving sustainable best practices for a data integrity program and sample management.ResponsibilitiesDuring the facility completion stage, this position is responsible for:

  • Planning, overseeing, organizing, directing, and reviewing routine QC activities to support ongoing manufacturing activities, final testing of finished products, and qualification/validation of analytical methods as needed, to ensure safety, reliability, and compliance of CRISPR products. -
  • Working closely with QA, MSAT and analytical development SMEs to develop and own sampling plans for manufacturing campaigns. Supporting and guiding the release of raw materials. - Developing the QC Data Integrity System, including ownership related policies and SOPs.
  • Managing laboratory personnel as direct reports, manage their work assignments, organize workload and help prioritize multiple tasks, reviewing data to ensure technical accuracy and compliance, and release of the results. - Mentor and train team members on applicable techniques, methods, and equipment.
  • Ensure safety rules are followed during all QC laboratory operations and follow chemical, biosafety and hygiene safety plans.
  • Managing any investigations of OOS, deviations, change controls, and CAPAs within QC Representing QC in all phases during the selection and implementation of LIMS and other quality systems, as applicable.
  • Leading the validation of electronic quality systems in QC and the implementation of the site's Sample Management Program.
  • Authoring, reviewing, and approving SOPs, protocols, and reports.Upon completion of facility commissioning and qualification, this position is responsible for:
    • Establishing and maintaining the sample and reference standard programs.
    • Creating training programs related to data integrity, LIMS, and sample management.
    • Supporting laboratory inspections and providing documentation to regulatory agencies.
    • Leading investigations, deviations, CAPAs, and change controls associated with LIMS and the Sample Management Program.
    • Participating in business sub-teams as a Subject Matter Expert to provide input on timeliness and to address QC data and sample related issues.
    • Performing other duties as needed.Minimum Qualifications
      • Bachelor's degree in Life Science, biochemistry, or related field.
      • A minimum of 8 years of relevant work experience in Quality Control or another regulated environment.
      • Experience leading teams of employees to successfully execute on goals and sitewide initiatives
      • Advance knowledge of LIMS applications and procedures.
      • Solid understanding of validation and maintenance of QC electronic systems and data integrity principles.
      • Previous experience with raw materials, samples, and reference standard programs for QC, preferable.
      • Strong understanding of applicable USP, ICH, and Ph Eur regulations related to QC testing.
      • Effectively collaborate with both internal and external stakeholders.
      • Ability to work independently and effectively, prioritize and deliver on tight timelines.
      • Outstanding problem-solving abilities.
      • Demonstrate ability to lead in a collaborative environment with a positive leadership style and hands-on approach that emphasize teamwork and consensus.Preferred Qualifications
        • Experience with cell therapies and/or AAV products
        • Master's degree in Life Science, biochemistry, or related fieldCompetencies
          • Collaborative - Openness, One Team
          • Undaunted - Fearless, Can-do attitude
          • Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
          • Entrepreneurial Spirit - Proactive. Ownership mindset.CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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Keywords: CRISPR Therapeutics, Framingham , Quality Control Lab Manager, Executive , Framingham, Massachusetts

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