Company Information
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 and natural killer (NK) cell-based immunotherapy.
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) in 2017. 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 Scientist II, Analytical Development as part of the Technical Development team based in Somerset, NJ.
Role Overview
This position will be responsible for developing, characterizing, transferring, qualifying and executing in QC analytical methods to be used in the manufacture of cellular therapy products. The candidate will have demonstrated proficiencies in method development in the areas of molecular biology, flow cytometry and / or functional assays. The individual will be responsible for assay design, execution and data analysis. 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 a Principal Scientist within Analytical Development.
Key Responsibilities
- Collaboratively drive projects to meet established timeline while maintaining the highest quality and data integrity standards
- Develop, characterize and optimize analytical methods including (but not limited to) flow cytometry, cell counts/viability, qPCR/ddPCR, ELISA, etc.
- Responsible for tech transfer of methods to QC and execution of methods in QC.
- Establish and author SOPs/procedures for methods developed.
- Maintain accurate and updated lab notebooks
- Maintain 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.
- Participate in technology transfers of product-specific methods to QC, to external partners and between sites. Contribute to method qualification activities.
- Provide analytical support for manufacturing and QC root cause investigations for OOS/OOE
- May author and / or review technical documents, protocols and / or reports
- Procure and qualify required materials to perform experiments or testing
- May work directly with external vendors to resolve reagent or equipment issues
- Responsible for ensuring effective, accurate and timely communication of project information.
Requirements
- BS/MS degree in cell/molecular biology, immunology or other related science. Technical training / certification desirable.
- BS degree: 3-5 years industry laboratory experience; MS degree: 1-3 yrs industry laboratory experience
- At least 2 years of developing analytical methods in support of process and product characterization of gene-modified products such as (but not limited to) PCR/qPCR/ddPCR, DNA/RNA isolation, flow cytometry, ELISA, cytokine measurements, cell proliferation measurements, apoptosis measurements, etc.
- Expertise with aseptic technique and mammalian cell culture, primary T cell culture experience required.
- Working in QC environment is a plus.
- Ability to communicate clearly with a variety of cross-functional teams
- Detail-oriented with expertise in problem solving and solid decision-making abilities
- Experience writing laboratory SOPs and technical instructions is preferred.
- Proficient in cGMP and ICH guidelines is preferred.
- Demonstrated ability to work independently and 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.
