CAR-T Cell Collections, Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Innovative Medicine

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!

Learn more at & Johnson is currently seeking a Lead CAR-T Cell Collection Operations to join our TEAM!

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 Biotech Inc. one of the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA Inc. have entered into a global strategic collaboration to develop manufacture and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

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!

Supported by their direct manager the CAR-T Cell Collection Operations Lead coordinates and maintains virtual supplier network of apheresis and cryopreservation starting material for clinical and commercial CAR-T products. With subject matter expertise they lead the technical relationship with Operating Company-level cell therapy teams and closely collaborate with commercial CAR-T teams. They will facilitate cell collection site certification activities related to apheresis and cell lab support/provide training for technicians/nurses as needed and facilitate near-real-time apheresis and/or cryopreservation quality investigation when required.

The Lead is responsible for effectively collaborating with hospitals as suppliers and completes appropriate technical analysis to assure quality services. They will maintain positive collaborations with other operation groups identifying options to improve performance. The Lead may implement programs to reduce supply base and achieve cost reduction goals. They will lead supplier capabilities including capacity planning and inventory management.

Key Responsibilities:

• Lead and maintain commercial CAR-T apheresis and cryopreservation activities in support of 400-500 CAR-T patient commercial supply chain activities.

• Serve as primary POC for apheresis center local cryopreservation cell laboratories as well as contracted third party apheresis/cryopreservation centers within assigned regions.

• Serve as apheresis Subject Matter Authority for internal and external teams.

• Facilitate and conduct site qualification and training for collections and/or cryopreservation requirements.

• Activate site as approved supplier prior to First Patient In (FPI) date.

• Ensure timely receipt of recall communications from apheresis centers and evaluate impact to product quality.

• Ensure timely release of quality fresh/cryopreserved apheresis starting material.

• Complete quality issues management within 24-48 hours post apheresis.

• Complete risk and change management.

• Develop solid understanding of information technology logistic transport and regulatory requirements affecting collection and cryopreservation of apheresis starting material.

• Maintain metrics to manage site performance.

Qualifications:

Education:

• Minimum of a Bachelors of Science or equivalent University Degree required; focused degree in Nursing Medical Laboratory Science or equivalent scientific or engineering field is preferred.

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience

• Minimum 2 years of relevant hands-on experience with Immunology Cell Biology Cellular Therapy or Apheresis

• Strong communication and interpersonal skills with the ability to work independently and in a cross-functional team environment to effectively support supplier relationship with 20-30 collection sites

• Ability to engage with hospital personnel to communicate specific and technical requirements for apheresis and cell cryopreservation

• Proven experience with Good Tissue Practices (GTP) and current Good Manufacturing Practices (cGMP)

• Flexibility to adapt to changing situations and ambiguity to prioritize tasks according to objectives and provide problem resolution

Preferred:

• Hospital experience or understanding of drug development and regulatory submission requirements

• Experience with quality issues management

• Project management experience

Other:

• Requires up to 25% domestic/international travel

• This position requires ability and flexibility to work on weekends/off hours for patient support and collaboration with a global team.

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 please contact us via or contact AskGS to be directed to your accommodation resource.

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