Car-t Cell Collection Operations, Lead

3 weeks ago

Raritan, United States Johnson & Johnson Full time

Johnson & Johnson is currently seeking a Lead CAR-T Cell Collection Operations to join our TEAM Remote work options may be considered on a case-by-case basis and if approved by the Company.

Janssen 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.

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 Bachelor’s 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, Cell 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 10-15 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

**Other**:

- Remote working environment to accommodate different US time zones is required
- Requires up to 25% domestic travel
- This position requires ability and flexibility to work on weekends/off hours for patient support.
- 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

  • CAR-T Cell Collection Operations, Lead

    4 weeks ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Lead CAR-T Cell Collection Operations to join our TEAM Remote work options may be considered on a case-by-case basis and if approved by the Company. 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,...

  • CAR-T Cell Collection Operations, Lead

    1 month ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Lead CAR-T Cell Collection Operations to join our TEAM Remote work options may be considered on a case-by-case basis and if approved by the Company. 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,...

  • Manager, Cell Science Msat Car-t

    7 days ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Manager, Cell Science MSAT CAR-T to join our Manufacturing Sciences and Technology (MSAT) Organization located in Spring House, PA or Raritan, NJ. Cancer immunology has rapidly progressed to one of the most promising forms of new treatments in which not the cancer, but the immune system is treated. This innovative...

  • CAR-T Manufacturing Operator

    2 days ago

    Raritan, United States Johnson & Johnson Full time

    Job DescriptionJanssen Pharmaceuticals, Inc. , a member of Johnson & Johnson's Family of Companies, is recruiting for a Manufacturing Operator, CAR-T located in Raritan, NJ . #CARTAt Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep...

  • CAR-T Manufacturing Operator

    1 week ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Job Description Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for aCAR-T Manufacturing Operatorlocated inRaritan, NJ. #CART 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,...

  • Car-t Manufacturing Operator

    2 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator located in Raritan, NJ. #CART : This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the...

  • CAR-T Manufacturing Operator

    4 weeks ago

    Raritan, United States Johnson & Johnson Full time

    DescriptionJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator 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...

  • CAR-T Manufacturing Operator

    3 weeks ago

    Raritan, United States Johnson & Johnson Full time

    DescriptionJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator 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...

  • Lentivirus (LVV) Manufacturing Operator, CAR-T

    1 month ago

    Raritan, United States Johnson & Johnson Full time

    JANSSEN PHARMACEUTICALS, INC., a member of Johnson & Johnson's Family of Companies, is recruiting for a LENTIVIRUS (LVV) MANUFACTURING OPERATOR located in RARITAN, NJ.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most...

  • Planner Vein to Vein Supply Chain Car T

    3 days ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Planner, Vein to Vein (V2V) Supply Chain - CAR-T to join our TEAM! 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...

  • Director, Car-t Strategic Program Lead

    3 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a **Director, CAR-T Strategic Program **Lead to join our TEAM! 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...

  • Car-t Warehouse Support Associate

    1 week ago

    Raritan, United States Johnson & Johnson Full time

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR T Warehouse Support Associate! **About Johnson & Johnson** Janssen 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,...

  • Director of Lenti Virus Operations Optimization and Competitiveness, CAR-T

    1 week ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Director of Lenti Virus Operations Optimization and Competitiveness to join our TEAMAt 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...

  • Senior Manager, CAR-T Batch Logistics

    4 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Description Johnson & Johnson is currently seeking a Senior Manager, CAR-T Batch Release Logistics 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...

  • Senior Manager, CAR-T Batch Logistics

    4 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Description Johnson & Johnson is currently seeking a Senior Manager, CAR-T Batch Release Logistics 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...

  • Cell Culturing Manufacturing Operator

    3 weeks ago

    Raritan, United States Johnson & Johnson Full time

    **Cell Culturing Manufacturing Operator (multiple openings)** **Manufacturing Operator, CAR-T** **DESCRIPTION**: **Janssen Pharmaceuticals, Inc. **, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Manufacturing Operator, CAR-T **located in **Raritan, NJ. **#CART. ***: This position is responsible for performing manufacturing...

  • Car-t Warehouse Process Specialist

    2 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Warehouse Process Specialist! Janssen 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...

  • Senior Director, Global Regulatory Leader, CAR-T Therapy

    1 week ago

    Raritan, New Jersey, United States Johnson & Johnson Full time

    Job Description - Senior Director, Global Regulatory Leader, CAR-T Therapy W) Senior Director, Global Regulatory Leader, CAR-T Therapy W Description Johnson & Johnson is currently seeking a Senior Director, Global Regulatory Leader for transformational chimeric antigen receptor T (CAR-T) cell products within the Oncology Therapeutic Area portfolio. This...

  • CAR-T Warehouse Support Associate

    1 week ago

    Raritan, New Jersey, United States J&J Family of Companies Full time

    CAR-T Warehouse Support Associate WDescriptionJanssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR T Warehouse Support AssociateAbout Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are...

  • Car-t Batch Logistics Planner

    2 weeks ago

    Raritan, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a CAR-T Batch Logistics Planner to join our TEAM! Remote work options may be considered on a case-by-case basis and if approved by the Company. 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...