Legend Biotech is seeking a Senior 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 Senior 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 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.
Establish donor eligibility criteria to support health authority filings and clinical manufacturing of allogeneic products.
Support GMP donor screening, collecting, and processing sites to ensure consistent external donor material collections for allogeneic manufacturing.
Collaborate 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.
Support 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

BS or MS Degree in Biology, Immunology, Biomedical Engineering, or other related sciences preferred.
Minimum 5-years of experience in cell and gene therapy or clinical setting utilizing blood collection.
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 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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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 law.

Legend Biotech maintains a drug-free workplace.