Job Description

Janssen Pharmaceuticals is currently hiring for a CAR-T Cell Collection Operations Manager to be located in Raritan, NJ and/or working remotely. Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.

Summary:

The CAR-T Cell Collection Operations Manager manages, coordinates, and maintains virtual supplier network of apheresis and cryopreservation starting material for clinical and commercial CAR-T products. Primary commercial CAR-T Janssen Supply Chain apheresis and cryopreservation. Subject Matter Expert who leads technical relationship with Operating Company level Cell Therapy teams. Closely collaborates with Commercial CAR-T teams. Facilitates cell collection site certification activities related to apheresis and cell lab. Supports and/or provides training for technicians/nurses as needed. Facilitates near-real-time apheresis and/or cryopreservation quality investigation when required. Responsible for ensuring optimized training program and site engagement method(s). Leads life-cycle site training and engagement with Cell Collection team regional operations managers and directors. Maintains awareness of industry standards related to apheresis and cell processing for CAR-T therapies.

Effectively collaborates with hospitals as suppliers and completes appropriate technical analysis to assure quality services. Systematically conducts, maintains, and manages key 'hospital as supplier' relationships. Maintains strong partnerships with other clinical and commercial operation groups in identifying options to improve performance. Implements programs to reduce supply base and achieve cost reduction goals. Executes process and cost improvements. Supports business case and cost/benefit analyses for management team to facilitate sound business decision-making, as needed Supports and maintains supplier quality management program(s) and manage supplier relationships. Manages supplier capabilities including but not limited to capacity planning, tooling and resource investments including inventory management and service level agreements. Provides global, and multi-site support.

Responsibilities:

Manage and maintain commercial CAR-T apheresis and cryopreservation activities in support of 2500-3000 CAR-T patient commercial supply chain activities annually.

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

Develop and apply fit for purpose harmonized customer-centric training

Facilitate and conduct site qualification and training for collections and/or cryopreservation of apheresis starting material. activating site as approved supplier, prior to FPI date

Lead Cell Collection training and site engagement enhancement

Create training tools and develop rubric to identify performance indicators related to training program/curriculum.

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

Ensure on-time release of quality fresh/cryopreserved apheresis starting material.

Execute issue management at collection or cryopreservation sites within 24-48 hours post apheresis.

Execute risk management, change management, recall, and lookback as it relates to apheresis starting material.

Develop working knowledge of information technology, logistic transport and regulatory requirements affecting collection and cryopreservation of apheresis starting material.

Maintain metrics to monitor site performance

Qualifications
A minimum of a bachelor's degree in a scientific or engineering discipline is required.

An Advanced degree (MS, PhD., Pharm. D., MD, RN) in a scientific discipline is strongly preferred.

A minimum of 8 years of relevant experience is required.

In depth working knowledge and conversant in GTP or cGMP is required.

Working knowledge and experience with leukapheresis or cell processing is required.

Working knowledge and experience in the treatment of hematologic malignancies including acute leukemias, non-Hodgkins lymphoma and multiple myeloma is preferred.

Stem cell transplant or apheresis experience and working with health agency established blood/tissue requirements is preferred.

Expertise in evolving health agency regulations regarding cell therapy or gene therapy is preferred.

Project Management skills and the ability to interface cross-functionally with clinical personnel is required.

Ability to work independently and in a matrixed team environment is required.

Ability to make decisions independently, innovative and strategic thinker with broad vision is required.

Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required.

Experienced quality assurance/compliance mindset is required.

Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.

Proficiency in Microsoft Word, Excel, PowerPoint; Microsoft project is required.

Understanding of drug development and submission requirements is preferred.

Manufacturing and logistics understanding/experience is preferred.

Previous experience as an educator, instructor, trainer, or related position, is preferred.

This position is located in Raritan, NJ and/or working remotely. Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado, and may require travel up to 30% of time both internationally and domestically.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan-1000 US HIghway 202
Other Locations
North America-United States
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Operations
Requisition ID
2105904284W