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Jobs · Information Technology · New Jersey

Scientist II, Analytical Development, Gene Editing and Molecular Assays

BioSpace · Somerset, NJ · 4 wk ago
On-siteInformation Technology$111k–$145k/yrFull-time

About the role

This position will be responsible for developing analytical methods and performing QC and in process sample testing to support the manufacture and characterization of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. The individual will be responsible for analytical methods development, qualification and internal or external transfer; routine testing of final product (GMP), stability, and in-process samples; and performing data review and verification, lab and instrument maintenance etc. The position will be responsible for maintaining accurate and contemporaneous records in a lab notebook and reporting results in a timely manner.

Responsibilities

  • Develop, optimize and qualify molecular biology methods for parameters such as: VCN, gene editing proficiency, infectious titer, genomic titer, rapid mycoplasma, surrogate RCL, residual DNA, etc.
  • Subject matter expert supporting routine testing of final product (GMP), stability, and in-process.
  • Perform review of testing data (e.g., data packets, final lot file, COA review).
  • Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
  • Cross trained in multiple complex analytical methods and/or multiple products.
  • Train others on multiple QC test methods, processes and procedures.
  • Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
  • Maintain accurate and updated lab notebooks.
  • Manage equipment and records for maintenance, calibration and operation. Contribute to maintenance of laboratory inventories.
  • Procure and qualify required materials to perform experiments or testing.
  • Work collaboratively with members of Analytical Development team to establish the analytical control strategy of the established methods.
  • Perform other tasks as assigned.

Requirements

  • BS, MS or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field.
  • A BS with 6-8 years of significant practical experience; a MS with 4-6 years of hands-on experience in QC testing and method development and qualification of gene and cell therapy products, Vaccine, Antibody, AAV, other Biologics; or a Ph.D. with 1-3 years of assay development experience in pharmaceutical field.
  • Demonstrated experience in assay development and GMP QC testing of Biologicals (e.g., qPCR, dPCR, ddPCR, ELISA, Cell culture and Cell based assays).
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
  • Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
  • Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Advanced knowledge of LIMS, ELN, Veeva, GraphPad Prism, JMP and laboratory data analysis systems preferred.
  • Expertise in analytical method qualification and validation, and tech transfer in In Vivo CAR-T, Vaccine, Antibody, AAV, or other Biologics is plus.
  • Strong communication skills, both written and verbal, with a demonstrated capacity to thrive in collaborative, team-driven environments.
  • Excel, Word, PowerPoint, etc
  • GraphPad Prism, other data analysis tools (PowerBI, JMP, etc)
  • ELN, LabVantage, etc
  • Mandarin preferred.

Benefits and Paid Time Off

  • Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
  • Eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
  • Additional voluntary 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.
  • Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay Range (Base Pay)

  • $110,706 - $145,303 USD

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

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