Principal Scientist - Flow Cytometry and Functional Assays, Analytical Development

Legend Biotech is seeking an Principal Scientist - Flow Cytometry and Functional Assays, 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 flow cytometry and other cell-based assays. 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 of assays from R&D teams to advance assays towards 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 multi-color flow cytometry methods such as (but not limited to) phenotyping of T, B, NK and other cells of the immune system, proliferation assays, apoptosis assays, cell cycle analysis and intracellular staining assays.
  
• Develop and optimize functional assay technologies such as (but not limited to) cell line engineering to build reporter gene assays, flow cytometry, cytotoxicity assays, and cytokine release assays.
  
•  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 to QC and execution in QC product-specific methods and / or to external partners and between sites. Lead method qualification activities.
  
• Provide analytical support as SME for manufacturing and QC root cause investigations for OOS/OOE
  
• 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. 

• PhD degree in immunology, cell biology, biomedical engineering or other related science. Technical training / certification desirable.
• 7-15 years’ experience in method development of gene-modified products
• Expertise in analytical method development and qualification/validation is required.
• Authored source documents and / or sections of regulatory submissions is preferred.
• Expertise in mentoring and scientific leadership.
• Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays.
• Detail-oriented with expertise in problem solving and solid decision-making abilities
  
• Excellent presentation skills and scientific/technical writing skills
  
• Proficient in cGMP and ICH guidelines is preferred.
• Ability to operate independently and lead a team environment.
• Language(s): English and Mandarin is desired.

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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.