CAR-T is an innovative treatment which uses the power of the patients own immune system. A patients T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. Janssen Biotech is working to develop manufacture and commercialize products in the CAR-T space.

The Cell Therapy Senior Principal Engineer is part of the Operations workstream and closely connected to the Quality and Tech Transfer workstream. You will act as a decision maker in the Operations workstream with responsibilities to shape the manufacturability of the R&D process collaborate in the development and own set-up of supply chain technology and processes for a new facility design. By collaborating with various other functions (MSAT R&D Engineering quality assurance quality control health and safety information technology operations planning etc.) you will support the successful transfer of the CAR-T process the timely start of clinical and commercial manufacturing and further improvement and scale-up of the process. The overall goal is creation of a compliant reliable cost competitive commercialized facility.

Key Responsibilities:

At the beginning of the facility design this role will require a broad range of knowledge and will transition to operational readiness and facility startup with ownership of specific areas of the Manufacturing process and all related requirements including the following responsibilities:

• Provide Operational expertise in the Technical Operations discussions based upon a combination of GMP knowledge of facility design knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products.
• Provide Operational expertise in the R&D process to support reliable repeatable GMP manufacturability of the process in development.
• Provide Operational guidance to the facility resource model. Leverage the model to shape the product development and operational processes to deliver solutions for cost competitiveness.
• Lead the development of user requirements for new technology and processes translate the requirements into operational performance efficiencies and impacts.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Find opportunities for improvement in your area and lead their development and implementation.
• Immerse yourself in CAR-T processes build up proven expertise ensure timely development and implementation of a robust operational documentation framework including operating procedures work instructions (electronic) batch records etc. and ensure adequate training of the organization.
• Ensure end-to-end overview of the flow of all material required in your area including process material documents waste samples.
• Identify risks and opportunities in relation to process contamination cross-contamination and mix-up control on the shop floor and drive follow-up initiatives for improvement in close cooperation with operators QA QC and operations management.
• Act as a lead in root cause related to safety/quality issues in your area.
• Act as a spokesperson for your area during health care inspections.
• Support the lean design and implementation of Information Technology systems (SAP MESetc) including future releases to continuously improve performance and compliance.
• As Ops SME represent Operations in Process Design and Process Qualification.
• Instill an approach of high standards of safety and cGMP compliance ensuring the reliability of your operations and readiness for audits or inspections at all times.
• Develop an appropriate governance structure to monitor the operational performance of your area at acceptance testing startup and ongoing.

Furthermore a portion of your time will be focused on developing detailed knowledge of the CAR-T production system:

• Develop & maintain in depth understanding of the mfg. processes (incl. sound scientific understanding) operational procedures and manufacturing environment (Facilities Utilities Equipment Systems Processes)
• Develop & maintain robust understanding of aseptic and cell processing techniques.
• Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)
• Understand biosafety.

Qualifications:

Education:

• Minimum of a Bachelors or equivalent University Degree required; advanced degree or focused degree preferred in Engineering Bioscience Engineering Industrial Engineering Pharmacy Biochemistry or related field.

Experience and Skills:

Required:

• Minimum 6 years of relevant work experience.
• Experience in one of more of the following areas: cGMP manufacturing operations technology development tech transfer process and equipment validation and/or quality management
• Demonstrated ability to collaborate internally and externally within a matrix environment.
• You place our patients at the center of everything you do.
• You embrace diversity equity and inclusion.
• Experience and/or knowledge of GMP shop floor manufacturing processes
• You have a start-up/can-do attitude and you proactively search for solutions.
• Strong prioritization skills to provide clear instructions to peers
• Experience working in a rapidly changing environment and lead as a change agent to promote flexibility creativity and accountability while at the same time handling procedures/ guidelines which require strict execution.
• Strong verbal and written communication skills with ability to influence without authority.
• Ability to work independently and successfully prioritizing and managing multiple tasks simultaneously and integrating multi-functional issues.
• Strong presentation skills to summarize and communicate results.

Preferred:

• Experience with equipment/systems commissioning/qualification/validation deploying new technology into operations IT/Automation systems
• Experience working in Cell gene therapy(CAR-T)

Other:

• Requires up to 10% domestic and/or international travel.
• This role will start as a hybrid role with co-locating at Engineering Design firm. Role will transition to site based to support installation qualification and startup.
• The anticipated pay range is 00

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: