Principal Scientist - Cell Sciences

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Principal Scientist - Cell Sciences as part of the Technical Development team based in Somerset, NJ.

Role Overview

Legend Biotech USA, Inc. is seeking a diverse, flexible, and driven scientific leader to join our Technical Development team. This Principal Scientist in Cell Sourcing will report to the Cell Sciences Lead and be responsible for overseeing sourcing of cellular starting materials associated with allogeneic and autologous cell therapy products. The successful candidate will be an integral member of the Technical Development and Technical Support team who will facilitate and manage the technical onboarding of clinical sites for autologous programs, including site evaluation, audits, process assessments and drafting of technical reports in a Quality Management System. The candidate will also support the sourcing of patient apheresis material from clinical site partners to be used in GMP manufacturing, cell line development and establishment, as well as supporting development of new allogeneic cell starting material technologies. He or she will also collaborate with internal and external partners to ensure externally manufactured GMP products-including, but not limited to, donor starting material and patient cell starting material, meet technical acceptance criteria, logistics and disposition criteria, health authority guidelines and global qualification standards.

Key Responsibilities

• Partner with cross functional team and lead technical evaluation to ensure clinical apheresis centers provide consistent apheresis collections for autologous patient manufacturing.
• Perform audits and develop technical reports for clinical apheresis centers and laboratories as a subject matter expert to support the onboarding of additional clinical sites for autologous programs.
• Act as a subject matter expert for apheresis collection, processing, cryopreservation and cold chain logistics supporting current and future autologous clinical trials.
• Author and review GMP investigations associated with laboratory and cold chain logistics deviations at clinical sites.
• Lead establishment of donor eligibility criteria to support health authority filings and clinical manufacturing of allogeneic products.
• Manage GMP donor screening, collecting, and processing sites to ensure consistent external donor material collections for allogeneic manufacturing.
• Leverage expertise to develop strategy with technical development scientists to implement testing of apheresis and other starting material to ensure success of allogeneic donor screening campaigns for successful cell therapy manufacturing.
• Oversee the development of cell lines for development and potential GMP use.
• Collaborate with internal quality representatives to ensure GMP practices are followed by external partners and appropriate controls are implemented.
• Coordinate, author, and review technical procedures, SOPs, and reports
• Key Relationships:
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact cross-functionally with all relevant departments and levels within the organization.

Requirements

• Minimum 8 years of experience in cell and gene therapy, clinical setting utilizing blood collection, engineering and/or biologics.
• 3+ years working with cellular starting material development experience in cell therapy preferred.
• Additionally, experience sourcing cellular starting material for development or clinical use.
• Experience with sourcing PBMCs, leukopaks, and cord blood a plus.
• Knowledge and experience working under cGTP/cGMP guidelines.
• Experience in working with varying cell starting material in cell and gene therapy.
• Expertise in working with generation and characterization of GMP cell lines a plus.
• CAR-T Process development or manufacturing a plus.
• Detail-oriented with expertise in problem solving and decision-making abilities.
• Strong presentation and verbal communication skills
• Understanding of cell starting material, cell biology, and/or CAR-T development/processing.
• Experience in handling and processing apheresis material.
• Knowledge of cGLP, cGTP and cGMP guidelines.
• Understanding of clinical site onboarding and startup for autologous clinical trials.
• Experience auditing external partners.
• Experience in establishing donor eligibility supporting allogeneic clinical trials is a plus.
• Experience in cold chain logistics is a plus.
• Experience in allogeneic starting material development is a plus.
• Ability to take initiative and responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
• Detail-oriented, excellent organizational skills with expertise in problem solving and solid decision-making abilities
• Strong written and verbal communication skills are essential Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.

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The anticipated base pay range for this is: $123,605 - $169,958 USD.

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.