Manager, CAR-T Cell Collection Operations

Job not on LinkedIn

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $102k - $177.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• Manage and maintain commercial CAR-T apheresis and cryopreservation activities supporting 2,500–3,000 CAR-T patient commercial supply chain activities • Serve as primary point of contact for apheresis centers, local cryopreservation cell laboratories, and contracted third-party centers • Serve as apheresis Subject Matter Authority for internal and external teams • Facilitate and conduct site qualification and training for collection and cryopreservation requirements • Activate sites as approved suppliers before First Patient In (FPI) • Ensure timely receipt of recall communications and evaluate product-quality impact • Ensure timely release of quality fresh/cryopreserved apheresis starting material • Complete quality issue management within 24–48 hours post-apheresis • Complete risk and change management • Develop understanding of information technology, logistics transport, and regulatory requirements affecting apheresis starting material • Maintain metrics to manage site performance • Coordinate and maintain a virtual supplier network of apheresis and cryopreservation starting material • Lead technical relationships with cell therapy teams and collaborate with commercial CAR-T teams • Facilitate near-real-time apheresis and cryopreservation quality investigations • Collaborate with hospitals as suppliers and conduct technical analyses to ensure quality services • Identify performance-improvement options and potentially implement supply-base reduction and cost-reduction programs • Lead supplier capacity planning and inventory management • Provide global and multi-site support

🎯 Requirements

• Minimum of a Bachelor’s/University or equivalent degree required • Minimum 6 years of relevant work experience • Hands-on experience with Immunology, Cell Biology, Cell Therapy, Apheresis, and/or Cryopreservation • Strong communication and interpersonal skills • Ability to work independently and in a cross-functional team environment • 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, prioritize tasks, and provide problem resolution • Strong written and verbal communication skills • Requires up to 15% domestic and international travel • Requires ability and flexibility to work on weekends/off hours for patient support and accommodate different global time zones • Focused degree in Nursing, Medical Laboratory Science, or equivalent scientific or engineering field is preferred • Hospital experience or understanding of drug development and regulatory submission requirements is preferred • Experience with quality issues management is preferred

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Vacation –120 hours per calendar year • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year • Holiday pay, including Floating Holidays –13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period10 days • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Inclusive interview process and disability accommodations