Technical Fellow (Director), Advanced Therapies -MSAT

Technical Fellow (Director), Advanced Therapies -MSAT

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Technical Fellow (Director), Advanced Therapies -MSAT to be in Raritan, NJ or Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose :

The Technical Fellow serves as a subject matter expert (SME) in CAR-T manufacturing and Quality Control analysis, playing a pivotal role in ensuring the quality and safety of cellular therapies. This position is critical in addressing challenges that arise when non-conforming products or deviations are generated during the manufacturing process, which can impact patient treatment. This role requires deep expertise in key areas, including apheresis collection, cryopreservation, cell processing, quality control testing, and quality release processes. The Technical Fellow provides insights to both internal manufacturing teams and external partners, ensuring adherence to the highest standards of quality. The Technical Fellow is also an integral member of various site / network operational teams, including planning, release, clinical / commercial rapid response teams, safety management, and site escalations. In this capacity, they contribute to the development of robust strategies that maintain the validated state of cell therapy processes while supporting lifecycle management initiatives involving new technologies, automation, and technology transfer.

Finally, this role serves as a key thought leader and scientific expert driving manufacturing trend investigation teams towards root cause identification. Proactively identifying complex scientific correlations linking deep univariate and multivariate data analyses to T-cell biology fundamentals, these role partners with development and site technical operations teams to drive towards robust conclusions. Through successful investigation, complex trends can be addressed by reducing non-conformance rates, aiding patients in need of rapid treatment.

This position is essential for enabling the CARVYKTI network's technical, supply chain, and compliance-related objectives. Collaborating across a complex network of internal and external stakeholders, this role drives improvements in patient care and enhances the overall efficiency of CAR-T therapy delivery.

You will be responsible for :

• Provide deep subject matter expertise to batch advocacy efforts for non-conforming products, leading manufacturing trend investigations and supporting root cause identification
• Engage with key opinion leaders in cell therapy space, academics, physicians, hospital / medical centers lead to drive down patient related contributions to non-conforming product. Engage with new markets to set up for success during the initial launch period (aiding in education on patient factors / contributions to manufacturing success)
• Provide deep subject matter expertise on initiatives aimed at reducing non-conforming product rates, through projects that may / may not require regulatory approval
• Provide technical support to regulatory filings, regulatory inspections, and health authority questions.

Qualifications :

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.

Required Skills : Agile Decision Making, Consulting, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Manufacturing Standards, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Scheduling, Resource Planning, Science, Technology, Engineering, and Math (STEM) Application, Stakeholder Engagement, Technical Research

Preferred Skills : Agile Decision Making, Consulting, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Manufacturing Standards, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Scheduling, Resource Planning, Science, Technology, Engineering, and Math (STEM) Application, Stakeholder Engagement, Technical Research

The anticipated base pay range for this position is : $146,000 to $251,850. Additional Description for Pay Transparency : 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)). Employees are eligible for the following time off benefits : vacation up to 120 hours per calendar year, 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, holiday pay, including Floating Holidays up to 13 days per calendar year, work, personal and family time - up to 40 hours per calendar year. Additional information can be found through the link below.