Legend Biotech is seeking an Principal 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.

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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.