Associate Director, Functional Assays and Flow Cytometry, Analytical Development

Legend Biotech is seeking an Associate Director Functional Assay and Flow Cytometry, Analytical Development as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Associate Director, Functional Assays and Flow Cytometry will be responsible for directing the establishment and optimization of 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 proficiency in the development of multiple types of assays including cell-based functional assays, immunoassays, biochemical assays, and flow cytometry assays. This will include setting strategy in creating a relevant analytical toolbox as well as performing appropriate QC transfer and qualification for methods promoted for release. The individual will be responsible for directing, leading and coordinating assay design, assay execution, and data analysis. The candidate will have had method qualification/validation experience and a proficiency in regulatory requirement for method qualification/validation using phase appropriate compliance approach. The position demands strong technical, and strategic CMC leadership within a collaborative, science-based, and patient-focused environment.

Key Responsibilities  

• Lead empowered analytical function, bioanalytical and flow assay development team to create and refine the method development, qualification, validation approaches for rapidly delivering phase-appropriate analytical components of projects with scientific excellence and patient-focus.
• Guide and 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/QC operations and identify critical parameters within assays
  for qualification activities.
• Direct method development forward through collaborative involvement or through mentoring and guiding direct reports.
• Direct and guide the team to develop functional assays (e.g., cell-based) and bioanalytical assays (e.g., ELISA).
• Direct and guide the team to 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.
• Ability to direct the team to design, execute 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.
• Establish and author SOPs/procedures for methods developed for use in QC release testing.
• Collaborate with QC functional lead to direct analytical/QC staff in performing functional, bioanalytical and flow assays for product release and/or characterization.
• Author and / or review technical reports, sections of regulatory filings (e.g., CMC sections of IND) and external scientific publications.
• Ensure team will be able to maintain accurate and updated lab notebooks and QC records.
• Ensure team will be able to manage equipment and records for maintenance, calibration and operation, and maintain laboratory inventories.
• Analyze data for trends and recommendations for scientific staff. Present analyzed data within and across departmental meetings.
• Direct and guide 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. 
• Direct the team to work collaboratively within the Analytical Development team to establish the analytical control strategy of the established methods.

• Advanced degree (PhD) in immunology, cell biology, biomedical engineering, or equivalent. Technical training / certification desirable.
• 7-15 years of experience in method development of gene-modified products in analytical development and/or QC in a biotech, academic, or pharmaceutical setting.
• Expertise in analytical method development and qualification/validation is required.
• Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays.
• Guide the design and execution of method qualification/validation.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Participate in cross-functional project teams to advance products towards and through clinical trials.
• Stay current on the latest advancements in assay development and apply relevant knowledge to guide the analytical development activities.
• Knowledge and experience with viral vectors, gene editing analytics are a plus.
• Authored source documents and / or sections of regulatory submissions is preferred.
• 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.
• Excellent leadership, emotional intelligence, and communication skills.
• Expertise in mentoring and scientific leadership.
• Composure during challenging times.
• Ability to lead in 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.