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Senior Scientist, Molecular Biology Analytics - Analytical Development

Somerset, New Jersey, United States

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 an Senior Scientist, Molecular Biology Analytics - Analytical Development as part of the Technical Development team based in Somerset, NJ. 

Role Overview

This position will be responsible for establishing and optimizing analytical methods to be used in the manufacture and characterization of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. The candidate will have demonstrated proficiencies in method development in the areas of molecular biology and viral vector biology. The individual will be responsible for leading and coordinating assay design, executing assays and the data analysis. The candidate will have had method qualification/validation experience and a proficiency in regulatory requirements for method validation. The position will be responsible for maintaining accurate and contemporaneous records in a lab notebook and reporting results in a timely manner. This role will report to the Director of Analytical Development.

Key Responsibilities  

  • Drive method development to meet established timeline while maintaining the highest quality and data integrity standards. Lead efforts in tech transfer or assays from R&D teams to advance assays toward GMP operations and identify critical parameters within assays for qualification activities.
  • Direct method development forward through collaborative involvement or through mentoring of direct reports.
  • Develop and optimize molecular biology methods for parameters such as: VCN, gene editing proficiency, infectious titer, genomic titer, rapid mycoplasma, surrogate RCL, residual DNA, etc.
  • Proficient in ddPCR/dPCR technologies with experiences in evaluating gene edited products. Direct experience with establishing libraries for sequencing and / or analysis of sequencing data for gene edited products is a plus.
  • Ability to design, execute and / or direct the development and qualification of release, characterization, and stability assays for testing of a clinical trial (first-in-human/new IND) and in support of product and process development. May also execute qualified methods in QC environment.
  • Establish and author SOPs/procedures for methods developed. Author and / or review technical reports, sections of regulatory filings (e.g., IND) and external scientific publications.
  • Maintain accurate and updated lab notebooks.
  • Manage equipment and records for maintenance, calibration and operation. Contribute to maintenance of laboratory inventories.
  • Analyze data for trends and recommendations for scientific staff. Present analyzed data within and across departmental meetings.
  • Act as Subject Matter Expert (SME) in technology transfers of product-specific methods to QC, to external partners and between sites. Contribute to method qualification activities.
  • Provide analytical support as SME for manufacturing and QC root cause investigations for OOS/OOE
  • Procure and qualify required materials to perform experiments or testing.
  • May work directly with external vendors to resolve reagent or equipment issues.
  • May participate in audits of 3rd party vendors as SME.
  • Work collaboratively with member(s) of Analytical Development team to establish the analytical control strategy of the established methods.

Requirements

  • PhD degree in cell/molecular biology, virology, immunology or other related science.
  • 7-15 years’ experience in method development of gene-modified products.
  • Expertise in analytical method development and validation is required.
  • Authored source documents and / or sections of regulatory submissions is preferred.
  • Strong written and verbal communication skills are essential.
  • Expertise in mentoring and scientific leadership.
  • Understanding of viral vector technology, design & manufacturing for gene or cell therapies is preferred.
  • Detail-oriented with expertise in problem solving and solid decision-making abilities.
  • Excellent presentation skills and scientific/technical writing skills.
  • Ability to operate independently and lead a team environment.
  • Language(s): English and Mandarin is desired.

#Li-JK1

#Li-Hybrid

The anticipated base pay range for this is: $142,146 - $195,452 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.

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