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Manufacturing Supervisor (Multiple Openings)

Company: CRISPR Therapeutics
Location: Framingham
Posted on: May 17, 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 SummaryReporting to the Manufacturing Sr. Director, the Manufacturing Supervisor will conduct aseptic Cell and Gene Therapy GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. - A successful candidate will be responsible for overseeing and performing the manufacture of allogenic and autologous gene edited cell therapies for clinical studies and as a commercial product. - This role requires clear communication across multiple departments for the execution of daily activities. - The ideal candidate will have experience successfully managing individuals while performing daily manufacturing operations.Responsibilities

  • Perform clinical -/ commercial -product manufacturing for -a -cell -and gene -therapy according to cGMP standards -and SOPs. -
  • Review and approval of completed Manufacturing documents and records
  • Supervise routine and non-routine manufacturing operations
  • Participates in technology transfer -from Process Development -to the Manufacturing group. - -
  • Development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with -PD / MSAT -and Quality Systems groups. - -
  • Develop and revise training requirements as needed.
  • Work collaborative with internal departments to ensure that the manufacturing schedule is maintained.
  • Ensures -all materials and equipment are -identified and -available in time for manufacturing activities. - -
  • Lead Quality investigation documentation and resolutions.
  • Prioritize, initiates, and implements Quality improvements. -
  • Ensures cGMP compliance through consistent execution. -
  • Provide verbal and written updates to Manufacturing leadership and departmental management.
  • Other duties and projects as assigned to meet departmental requirements. -
  • Scheduling activities to ensure sufficient operator coverage.
  • Available to work a flexible schedule as needed. -Minimum Qualifications
    • Associate or bachelor's degree or higher in biology or other related fields
    • 7 or more years of relevant aseptic cell culture experience
    • Available to work a flexible schedule as needed. -
    • Comprehensive knowledge of GMP and industry standards
    • Experience working in quality systems (e.g., documentation, deviations, CAPAs)
    • Strong fluency in Windows and Microsoft Office applications
    • Experience with MES and integrated automation platforms
    • Attentive to detail and -accuracy -
    • Ability to effectively supervise the manufacturing team performing operations in multiple suites
    • Ability to effectively communicate and collaborate with internal and external stakeholders is essential
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion.
    • Self-driven, independently motivated, data driven and excellent problem-solving ability.Preferred Qualifications
      • Prior experience in cell or gene therapy manufacturingCompetencies
        • 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 , Manufacturing Supervisor (Multiple Openings), Other , Framingham, Massachusetts

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