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

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 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 the First Patient In date • Ensure timely receipt of recall communications and evaluate impact to product quality • Ensure timely release of quality fresh and 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 collection and cryopreservation • Maintain metrics to manage site performance • Collaborate with hospital suppliers, operating company cell therapy teams, commercial CAR-T teams, and other operations groups • Lead supplier capabilities, including capacity planning and inventory management • Implement programs to reduce the supply base and achieve cost reduction goals • 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 an 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, including investigations, deviations, and CAPAs, is preferred

🏖️ Benefits

• Pension plan • 401(k) savings plan • 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 period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year • Inclusive interview process and disability accommodations