Senior Scientist, Analytical Development (FFBA)

Requirements

• Advanced degree (PhD or Master) in immunology, cell biology, biomedical engineering, or equivalent. 5-8 years (PhD) or 8-10 years (Master) of experience in method development of gene-modified products in analytical development and/or QC in a biotech, or pharmaceutical setting. Technical training / certification is desirable.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Expertise in analytical method development and qualification is required (Vaccine, Biologics, Viral Vector, or CGT).
• Solid understanding of ICH guidelines and regulatory expectations for method development and qualification/validation.
• Expertise in analytical method development and validation in late stage is preferred.
• Experience in analytical comparability strategy, method bridging, method transfer activities for early and late phase in product development. Global experience is a plus.
• Experience in developing lentiviral vector product releasing and characterization methods including multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Deep understanding and experience in analytical data trending, critical reagent and material determination and qualification, establishment of product releasing specification for early and late stage product development.
• Guide the establishing and authoring of SOPs/procedures, protocols, and reports for analytical methods and activities.
• Authorship in IND/BLA preparation is preferred.
• Demonstrated ability to lead, mentor, and develop junior staff in a matrixed and collaborative environment.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Experience implementing or executing compendial methods (HPLC, Ph, Osmolality, Particulate Matter, etc) is preferred.
• Excellent presentation skills, scientific/technical writing skills, and communication skills.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Experience with:
• Excel, Word, PowerPoint, etc
• GraphPad Prism, other data analysis tools (PowerBI, JUMP, R)
• CytoExpert, FCS express, NovoExpress, FlowJo, etc
• ELN, LabVantage, etc.
• Language(s): Strong written and verbal English skills are required. Mandarin preferred.
• AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.
• #Li-JR1
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• The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
• Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
• 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. We offer 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. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
• Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
• Work Authorization & Employment Eligibility
• Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.
• 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.
• Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.