Johnson & Johnson Innovative Medicine
Technical Lead, Advanced Therapies MS&T (Cell Therapy)
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Technical Lead, Advanced Therapies MS&T (Cell Therapy)
Join to apply for the
Technical Lead, Advanced Therapies MS&T (Cell Therapy)
role at
Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Summary The Technical Lead, Advanced Therapies Supply Chain MS&T supports the Raritan MS&T team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving. They will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
Key Responsibilities
Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously.
Integrate cross-functional issues and balance competing priorities effectively; manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
Ensure MES (manufacturing execution system) matches technical process; equations/instructions/workflows are correct and engineering controls are appropriate and optimal.
Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment.
Work cross-functionally across MS&T and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing.
Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Qualifications
A minimum of a Bachelor’s degree or equivalent University degree is required; degree in Engineering or Advanced degree is preferred.
Minimum 6 years of operations experience within a cGMP environment in biotech/biopharma industry is required, and a minimum of 2 years experience in cell / gene therapy cGMP manufacturing experience is strongly preferred.
Experience in building strong partnerships and effectively integrating with external collaborators to drive projects/programs forward in a matrixed environment.
An ability to build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
Prior working knowledge and experience with MES systems in a GMP environment.
Clear and succinct verbal and written communication skills.
Other Requirements
Ability and flexibility to accommodate changes in the schedule and working in other shifts including evenings and weekends as required by the manufacturing process.
Ability to accommodate unplanned overtime on little to no prior notice.
Compensation The anticipated base pay range for this position is $115,000 to $197,800.
Benefits Johnson & Johnson maintains highly competitive, performance-based compensation programs. The position is eligible for an annual performance bonus and the Company’s long-term incentive program. Employees may also participate in the Company’s consolidated retirement plan (401(k)), medical, dental, vision, life insurance, short- and long-term disability, and group legal insurance benefits. Time off benefits include vacation, sick time, floating holidays, and other paid time off.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
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Technical Lead, Advanced Therapies MS&T (Cell Therapy)
role at
Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.
Summary The Technical Lead, Advanced Therapies Supply Chain MS&T supports the Raritan MS&T team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving. They will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
Key Responsibilities
Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously.
Integrate cross-functional issues and balance competing priorities effectively; manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
Ensure MES (manufacturing execution system) matches technical process; equations/instructions/workflows are correct and engineering controls are appropriate and optimal.
Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment.
Work cross-functionally across MS&T and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing.
Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Qualifications
A minimum of a Bachelor’s degree or equivalent University degree is required; degree in Engineering or Advanced degree is preferred.
Minimum 6 years of operations experience within a cGMP environment in biotech/biopharma industry is required, and a minimum of 2 years experience in cell / gene therapy cGMP manufacturing experience is strongly preferred.
Experience in building strong partnerships and effectively integrating with external collaborators to drive projects/programs forward in a matrixed environment.
An ability to build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
Prior working knowledge and experience with MES systems in a GMP environment.
Clear and succinct verbal and written communication skills.
Other Requirements
Ability and flexibility to accommodate changes in the schedule and working in other shifts including evenings and weekends as required by the manufacturing process.
Ability to accommodate unplanned overtime on little to no prior notice.
Compensation The anticipated base pay range for this position is $115,000 to $197,800.
Benefits Johnson & Johnson maintains highly competitive, performance-based compensation programs. The position is eligible for an annual performance bonus and the Company’s long-term incentive program. Employees may also participate in the Company’s consolidated retirement plan (401(k)), medical, dental, vision, life insurance, short- and long-term disability, and group legal insurance benefits. Time off benefits include vacation, sick time, floating holidays, and other paid time off.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.
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