Tbwa Chiat/Day Inc
Metrology Specialist
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 productPlans, coordinates, and performs timely execution of daily activities related to calibration and instrumentationEnsures proper materials, tools, standards, parts and spare parts are identified and availablePerforms work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating proceduresSupports the planning, coordination, and performance of timely calibration during shutdownsResponsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicableParticipates in the development of calibration data sheets, metrology job plans and associated master plansParticipates in the development, implementation and sustainment of emergency response programs and other safety programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extensionPartner with stakeholders to assist in defining user requirements for new instrumentsResponsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes 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 improvementProvides technical expertise in area of responsibility by effectively interfacing and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric performance to drive team results in areas of EHS, quality, compliance, cost, delivery and peopleRequirements
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 certificationMinimally 4+ years of experience in cGMP cleanroom manufacturing experience under aseptic conditionsTechnical 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 tomorrowA history of being a member of high performing teams with a strong sense of missionCommunicates 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 situationsCapable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environmentExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levelsProven experience working and leading in a matrix environmentAbility to lead with influencecGMP manufacturingMetrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practicesComputerized 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 membersStrong analytical, problem solving and critical thinking skillsProject managementChange managementOperational excellence, continuous improvement and lean manufacturingExcellent organizational and communication skillsTransparent, Passionate, Fearless and Accountable
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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 productPlans, coordinates, and performs timely execution of daily activities related to calibration and instrumentationEnsures proper materials, tools, standards, parts and spare parts are identified and availablePerforms work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating proceduresSupports the planning, coordination, and performance of timely calibration during shutdownsResponsible for performance of IFM calibration outcomes; reviews CPI/KPI/GPI where applicableParticipates in the development of calibration data sheets, metrology job plans and associated master plansParticipates in the development, implementation and sustainment of emergency response programs and other safety programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical documentationConducts basic risk mitigation options and advanced troubleshooting to identify root cause and appropriate corrective actions for equipment system problemsHelps support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration interval extensionPartner with stakeholders to assist in defining user requirements for new instrumentsResponsible for working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes 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 improvementProvides technical expertise in area of responsibility by effectively interfacing and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric performance to drive team results in areas of EHS, quality, compliance, cost, delivery and peopleRequirements
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 certificationMinimally 4+ years of experience in cGMP cleanroom manufacturing experience under aseptic conditionsTechnical 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 tomorrowA history of being a member of high performing teams with a strong sense of missionCommunicates 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 situationsCapable of thriving in a fast-paced, challenging, entrepreneurial and team-oriented environmentExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levelsProven experience working and leading in a matrix environmentAbility to lead with influencecGMP manufacturingMetrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practicesComputerized 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 membersStrong analytical, problem solving and critical thinking skillsProject managementChange managementOperational excellence, continuous improvement and lean manufacturingExcellent organizational and communication skillsTransparent, Passionate, Fearless and Accountable
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