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Senior Principal Cell Therapy Engineer - 2406192193W

Description

Johnson & Johnson is currently recruiting for a Senior Principal Cell Therapy Engineer located in Raritan, NJ!

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, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong. CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s 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.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

The Cell Therapy Senior Principal Engineer will act as a decision maker in the Operations workstream and closely connected to the Quality and Tech Transfer workstream. You will shape the manufacturability of the 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 scale-up of the process. The overall goal is creation of a GMP, 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 intensive GMP knowledge of facility design, process manufacturability, knowledge in aseptic techniques and extensive process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products.

• 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.

• Own 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.

• Analyze manufacturing processes to find opportunities for optimization, efficiency improvements, and cost savings.

• Immerse yourself in CAR-T processes, build up solid 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 collaboration with operators, QA, QC and operations management.

• Act as a lead during health care inspections and root cause related to safety/quality issues in your area.

• Support the lean design and implementation of Information Technology systems (SAP, MES,etc) including future releases to continuously improve performance and compliance.

• As Ops SME, represent Operations in Process Design and Process Qualification.

• Instill an attitude of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.

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

Qualifications:

Education:

• Minimum of a Bachelor’s 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 8 years of relevant work experience.

• Experience in one of more of the following areas: cGMP manufacturing, cGMP facility design, operations technology development, tech transfer, process and equipment validation, and/or quality operations.

• 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.

• You have a start-up/can-do mindset, and you proactively search for solutions.

• You prioritize and provide clear instructions to peers.

• You thrive 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.

• You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.

Preferred :

• Experience with equipment/systems commissioning/qualification/validation, IT systems, cell therapy(CAR-T) is an asset.

Other:

• Requires up to 25% domestic and/or international travel.

The anticipated base pay range for this position is $118,000 - $203,600 USD.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

o Vacation – up to 120 hours per calendar year

o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

o Holiday pay, including Floating Holidays – up to 13 days per calendar year

o Work, Personal and Family Time - up to 40 hours per calendar year

Additional benefits information can be found at https://www.careers.jnj.com/employee-benefits.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-PA1

Primary Location NA-US-New Jersey-Raritan

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Job Function Process Engineering

Req ID: 2406192193W