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