Cell Therapy Liaison (1 of 2)

at J&J Family of Companies in Springfield, Illinois, United States

Job Description

Cell Therapy Liaison (1 of 2) – 2406202146W

Description

Johnson and Johnson is currently seeking a Cell Therapy Liaison . This position can be located remotely within the United States, Canada, or Europe.

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 https://www.jnj.com/.

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 equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Clinical Cell Therapy Liaison group is a global team within Janssen responsible for the clinical trials network for cell collection, cell processing laboratories, and cryopreservation sites.

The Cell Therapy Liaison (CTL) is a member of the Cell Therapy Platform team and serves as a cross-functional expert within Janssen to manage highly complex and novel technical aspects and logistics of treatment with human cells, tissues, and cellular and tissue-based products (HCT/Ps). This role provides expertise in establishing and maintaining processes including donor requirements, cell collection, cryopreservation, product handling, and storage for HCT/Ps. The CTL provides technical and operational support to clinical sites participating in Janssen global cell therapy trials.

The CTL is involved in the selection, evaluation, and initiation of hospitals that collect and process HCT/Ps; including clinical site evaluation, training, implementation of Janssen requirements, and oversight of processes related to HCT/P collection and processing.

The CTL works with Janssen Global Development, Global Clinical Operations, Drug Product, Development, and Supply (DPDS), Supply Chain, External Quality, and the Oncology Therapeutic Area (TA) to provide input into cell therapy process development.

Cell Therapy Liaisons are organized regionally providing expertise tailored to the local practices and regulatory requirements.

Primary responsibilities:

• Reviews clinical protocols to ensure alignment with donor requirements, cell collection, product handling, tracking and traceability, and IP storage

• Reviews clinical site cell therapy capabilities (protocol feasibility assessments) for inclusion in clinical trials

• Attends clinical site qualification visits for cell therapy trials to ensure compliance with relevant standards, regulations, and Janssen requirements

• Supports the development, implementation, and training of the Cell Therapy Product Procedures Manual (CTPPM) for cell therapy clinical trials

• Approves labels and onsite IP destruction

• Leads Logistics Test Run (LTR) with clinical trial teams to ensure compliance with CTPPM

• Supports cryopreservation site set up as per clinical trial protocols

• Maintains regular contact with Clinical Supply Chain (CSC) for scheduling updates and COC/COI (Chain of Custody/Chain of Identity) requirements

• Addresses Non-conformance issues in relation to scope of role. Serves as an SME for issues and deviations from collection sites and cryopreservation locations, to assess the impact on upstream and downstream activities

• Provide guidance to global and local clinical teams in current cell therapy standards and regulations

• Supports overall Cell Therapy platform initiatives to streamline cell therapy development within and across programs

• Mentor and develop others in cell therapy expertise

Qualifications

Education:

• Bachelor’s degree required, preferably in a scientific, technical, or clinical discipline (e.g., medical technology, nursing, life sciences)

Required:

• 3 years of experience in a cell therapy setting

• Knowledge of cell therapy standards and/or global pharmaceutical regulations (i.e., FACT/JACIE, GMP, GTP, GCP)

• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Excel)

• Ability to work independently and in a matrixed team environment

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

• Excellent oral and written communication skills

• Possesses a strong quality mindset, effective leadership skills, and proven ability to foster team productivity and cohesiveness

· Ability to collaborate with all levels of management

• Up to 20-25% travel – Domestic & International

Preferred:

• Stem cell transplant, apheresis collection, laboratory/cell manufacturing, quality, and/or cell therapy clinical operations experience

• Experience in and knowledge of the cell therapy and pharmaceutical development process

• Clinical Project Management skills and the ability to interface cross-functionally with clinical personnel

• Related industry experience: Cell Therapy, Pharmaceutical, Biopharmaceutical, Biotechnology

The anticipated base pay range for this position in the US is $113,000 to $195,500.

The anticipated base pay range for this position in San Francisco Bay Area is $139,000 to $224,825.

• The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on August 2, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Act