Scientist II, Process Development

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 Scientist II, Process Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Scientist, Process Development (PD) will be responsible for developing, establishing and optimizing processes to be used in the manufacturing of Legend's gene and cellular therapy pipeline and first-in-human/new IND products. The candidate will have demonstrated technical experience working in multidisciplinary research and process development labs to define robust manufacturing processes and/or associated analytical systems, supporting the development of scalable, cGMP-compliant processes and documentation for the manufacturing of novel allogeneic cellular and gene therapeutic products. This position requires prior experience with mammalian cell culture, process development for cellular and gene therapies and excellent technical, organizational, and interpersonal skills.

Key Responsibilities

• Under the leadership of senior level technical staff, support the design of complex process development studies.
• Ability to work within a team to deliver phase-appropriate process development components of projects with scientific excellence and patient-focus according to Technical Development and Company's strategic objectives.
• Work according to appropriate standards for quality, ethics, health, safety, environmental, protection and information security; participate activities that are aligned with organizational workflow and procedures.
• Ability to execute the development studies in the lab, document the procedure, and interpret process development experiment results.
• Ability to execute the bespoke manufacturing process in the GMP suite, document the procedure on MBR in a GMP compliant environment.
• Author technical protocols, technical reports, SOPs and MBRs for the manufacturing process.
• Ability to maintain accurate and updated lab notebooks and manufacturing records.
• Work within the team to manage equipment and records for maintenance, calibration, cleaning and operation, and lead the effort to maintain laboratory inventories.
• Provide technical support and expertise as SME for manufacturing root cause investigations for Deviations and CAPA.
• Ability to use statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in clear and concise manner.
• Author technical documents to support regulatory filings.
  Ability to work collaboratively with the EDD, Analytical Development, Material Science and other cross functional teams to support the establishment of development strategy for new product and supply materials to support pre-clinical studies and associated activities.
  Ability to use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Evening and weekend work as deemed necessary according to project timeline.

Requirements

• Advanced degree (BS, MS, PhD) in immunology, cell biology, biomedical engineering, or equivalent. Technical training / certification is desirable.
• 3-5 years of experience in process development of gene or gene-modified products in a biotech, academic, or pharmaceutical setting.
• Experience in biotechnology bioprocessing, gene and cell therapy process development and/or GMP manufacturing.
• Experience working with viral vectors and gene editing is a plus
• Authoring SOPs/procedures for established and new procedures.
• Ability to transfer processes to internal or external manufacturing sites.
• Ability to work independently and successfully prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Ability to work collaboratively with cross-functional teams.
• Stay current on the latest advancements in process development and apply relevant knowledge to guide the development activities.
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Excellent presentation skills and scientific/technical writing skills.
• Proficiency in cGMP and FDA guidelines is preferred.
• Excellent teamwork, emotional intelligence, and communication skills.
• Composure during challenging times.
• Ability to work in a team environment.
• Experience using statistical tools to analyze data (JMP, GraphPad etc.) and using visualization tools (PowerBI) to trend development and manufacturing data.
• English and Mandarin are preferred.

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The anticipated base pay range is

$107,482—$141,070 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.