Tbwa Chiat/Day Inc
Metrology Specialist (2nd shift)
Tbwa Chiat/Day Inc, Raritan, New Jersey, us, 08869
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking
Metrology Specialist
as part of the
Technical Operations
team based in
Raritan, NJ.Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require proven technical expertise and troubleshooting ability to drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.Key ResponsibilitiesProvides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product.Plans, coordinates, and performs timely execution of daily activities related to calibration and instrumentation.Ensures proper materials, tools, standards, parts and spare parts are identified and available.Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures.Supports the planning, coordination, and performance of timely calibration during shutdowns.Responsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable.Participates in the development of calibration data sheets, metrology job plans and associated master plans.Participates in the development, implementation and sustainment of emergency response programs and other safety programs.Assists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentation.Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.Helps support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extension.Partner with stakeholders to assist in defining user requirements for new instruments.Responsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment.Promotes a collaborative work environment focused on an EHS first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement.Provides technical expertise in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions.Actively participates in all regulatory and internal audits of the facility.Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.Helps improve metric performance to drive team results in areas of EHS, quality, compliance, cost, delivery and people.Requirements
B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade / Technical School Certification or Certification in Craft required. Military equivalent of Trade / Technical School certification.Minimally 4+ years of experience in cGMP cleanroom manufacturing experience under aseptic conditions.Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA).Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.A history of being a member of high performing teams with a strong sense of mission.Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations.Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment.Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels.Proven experience working and leading in a matrix environment.Ability to lead with influence.cGMP manufacturing.Metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices.Computerized maintenance management systems (CMMS).EHS and regulatory standards (e.g. EPA, OSHA and DEA).Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.Strong analytical, problem-solving and critical thinking skills.Project management.Change management.Operational excellence, continuous improvement and lean manufacturing.Excellent organizational and communication skills.Transparent, Passionate, Fearless and Accountable.Must be willing to work on one of the following schedules: Sun-Wed or Wed-Sat- 2:30PM-12:00AM. (Schedule is subject to change).
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Metrology Specialist
as part of the
Technical Operations
team based in
Raritan, NJ.Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy facility for commercial launch and sustained production. The role will require proven technical expertise and troubleshooting ability to drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.Key ResponsibilitiesProvides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T product.Plans, coordinates, and performs timely execution of daily activities related to calibration and instrumentation.Ensures proper materials, tools, standards, parts and spare parts are identified and available.Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures.Supports the planning, coordination, and performance of timely calibration during shutdowns.Responsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicable.Participates in the development of calibration data sheets, metrology job plans and associated master plans.Participates in the development, implementation and sustainment of emergency response programs and other safety programs.Assists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentation.Conducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problems.Helps support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extension.Partner with stakeholders to assist in defining user requirements for new instruments.Responsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipment.Promotes a collaborative work environment focused on an EHS first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvement.Provides technical expertise in area of responsibility by effectively interfacing and collaborating with key stakeholders and functions.Actively participates in all regulatory and internal audits of the facility.Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.Helps improve metric performance to drive team results in areas of EHS, quality, compliance, cost, delivery and people.Requirements
B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering related field. Trade / Technical School Certification or Certification in Craft required. Military equivalent of Trade / Technical School certification.Minimally 4+ years of experience in cGMP cleanroom manufacturing experience under aseptic conditions.Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA).Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with the need to extend and improve the planning horizon to prepare for tomorrow.A history of being a member of high performing teams with a strong sense of mission.Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations.Capable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environment.Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels.Proven experience working and leading in a matrix environment.Ability to lead with influence.cGMP manufacturing.Metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices.Computerized maintenance management systems (CMMS).EHS and regulatory standards (e.g. EPA, OSHA and DEA).Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.Strong analytical, problem-solving and critical thinking skills.Project management.Change management.Operational excellence, continuous improvement and lean manufacturing.Excellent organizational and communication skills.Transparent, Passionate, Fearless and Accountable.Must be willing to work on one of the following schedules: Sun-Wed or Wed-Sat- 2:30PM-12:00AM. (Schedule is subject to change).
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