Process CAR-T SME

该职位来源于猎聘 As the CAR-T Process SME, this role is responsible for

• Participate to the design and implementation of Process Engineering activities to support Exyte’s Strategic Plan for CAR-T processes
• Provide scientific knowledge and cGMP expertise in cell and gene therapy processes and process technologies to establish the appropriate holistic Process Control Strategy.
• Support and ensure cGMP readiness of the process through an appropriate strategy in compliance with regulations, procedures and the validation requirements
• Provide ad hoc scientific support to the Biotechnology and Life Science team and bring knowledge in order to allow development of new technologies and requirements to building and contamination control Main responsibilities：
• Serve as Subject Matter Expert (SME) to Exyte’s Biotechnology and Life Science team for cell therapy and CAR-T processes.
• Participate to the design and implementation of Process Engineering activities to support Exyte’s Strategic Plan for CAR-T processes.
• Provide support, scientific and technical expertise in the BLS Engineering and Business Development teams, own the process knowledge of the cell and gene therapy process technology to support technology driven activities into Exyte’s market presence.
• Participate to the establishment and maintenance of related Validation Master Plans.
• Design studies are necessary to successfully implement manufacturing process technology into the building design and process engineering. Draft/review documentation (plans, models, flow diagrams, instructions, training documents) and oversee execution of projects.
• Build knowledge/expertise within the teams to define robust Process and Contamination Control strategies.
• Draft Process Risk Assessments for the implementation of process and Changes.
• Support and ensure cGMP readiness of the process through appropriate plans and reports.
• Serve as Subject Matter Expert (SME) in preparation for and during internal and external regulatory reviews
• Provide ad hoc technical/scientific assessment, recommendations and support to cGMP documentation: Change Controls and deviations
• Assure regulatory compliance and technical feasibility of proposed changes.
• Identify opportunities for process, layout and environmental improvements related to safety, environmental, quality, compliance, productivity, and cost, and drive implementation to our clients’ benefit
• Partner with all relevant teams and/or client and vendor experts to suggest process and contamination control improvements.
• Technology watch: Keep up to date on the most recent CAR-T product & process updates (develop network of service providers & suppliers, participate to congresses…) and liaise with other technical development teams. Additional responsibilities：
• Delivers on-the-job knowledge sharing/training/mentoring within technical discipline
• Follows technological trends and maintains knowledge within technical discipline
• Supports development of new methods/tools/ for feasibility and CD execution and improve existing solutions supporting compliant facility planning
• Stays current in global regulations impacting facility attributes for the manufacture of biologics and pharmaceutical drug substance and drug product
• Integrates with other disciplines, both internal and Client resources, to optimize process / architecture / facility solutions
• Supports development of optimized architecture/facility standards for global use across the Company
• Ensures use of best practice within recognized Industry process / architecture / facility models
• Participates actively in relevant cross-organizational / cross site standardized solutions specifically for feasibility and conceptual design
• Participates in Industry forums to expand the growth of the Company and our Body of Knowledge
• Attends special courses/practical training in field of expertise
• Recognized expert within process architecture discipline, specific to biologics and pharmaceutical manufacturing
• Versed in global regulatory aspects of GMP related to facility design
• Adept at finding innovative methods and solutions for Customer / project / business requirements
• Fluent in the use of Visio and CAD platforms and other visual tools to present ideas and solutions
• Ability to communicate design solutions and use of methods, tools and technology in solutions, to a global audience
• A minimum of a Master degree in Engineering, Science, Chemical, Pharmaceutical or related field or equivalent experience required.
• Minimum 8 years of experience within a cGMP driven environment in the biotech / biopharma industry. Cell and Gene Therapy Experience is a must.
• Experience in the execution (design, build, start-up) of capex projects for drug substance and drug product manufacturing.
• Ability to work cross-functionally and successfully.
• High organizational skills: prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet multiple clients in a multiple country location environment
• Good communication skills in English and Chinese (both written and oral)
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment among clients and suppliers.
• A minimum of a Master degree in Engineering, Science, Chemical, Pharmaceutical or related field or equivalent experience required.
• Minimum 8 years of experience within a cGMP driven environment in the biotech / biopharma industry. Cell and Gene Therapy Experience is a must.
• Experience in the execution (design, build, start-up) of capex projects for drug substance and drug product manufacturing.
• Ability to work cross-functionally and successfully.
• High organizational skills: prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet multiple clients in a multiple country location environment
• Good communication skills in English and Chinese (both written and oral)
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment among clients and suppliers.
• A minimum of a Master degree in Engineering, Science, Chemical, Pharmaceutical or related field or equivalent experience required.
• Minimum 8 years of experience within a cGMP driven environment in the biotech / biopharma industry. Cell and Gene Therapy Experience is a must.
• Experience in the execution (design, build, start-up) of capex projects for drug substance and drug product manufacturing.
• Ability to work cross-functionally and successfully.
• High organizational skills: prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet multiple clients in a multiple country location environment
• Good communication skills in English and Chinese (both written and oral)
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment among clients and suppliers.

Qualifications

• A minimum of a Master degree in Engineering, Science, Chemical, Pharmaceutical or related field or equivalent experience required.
• Minimum 8 years of experience within a cGMP driven environment in the biotech / biopharma industry. Cell and Gene Therapy Experience is a must.
• Experience in the execution (design, build, start-up) of capex projects for drug substance and drug product manufacturing.
• Ability to work cross-functionally and successfully.
• High organizational skills: prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet multiple clients in a multiple country location environment
• Good communication skills in English and Chinese (both written and oral)
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment among clients and suppliers.