CRISPR Therapeutics Supervisor/Senior Supervisor, Cell and Gene Therapy Manufacturing in Framingham, Massachusetts
CRISPR 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 collaborations 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 based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
Reporting to the Manufacturing 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. The role will start as a M-F standard 8 hr. day shift during facility start up and tech transfer, eventually shifting to a 4x10 shift as production ramps up for ongoing production.
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.
Demonstrate CRISPR CUREs behaviors by being: Collaborative, Undaunted, Results-Oriented and Entrepreneurial.
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.
Associate or bachelor?s degree or higher in biology or other related fields
7 or more years of relevant aseptic cell culture experience
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.
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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