Scientist II, CMC Pipeline Innovation

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a **Scientist II, CMC Pipeline Innovation** as part of the **Technical Development** team based in **Somerset, NJ.** **Role Overview** The Scientist II, CMC Pipeline Innovation plays a key role in advancing innovative manufacturing, analytical, and characterization technologies that accelerate the development of cell and gene therapies. This position is responsible for the hands-on execution of process and analytical studies aimed at improving process understanding, product characterization, quality, scalability, speed, and cost efficiency across the development pipeline. Working closely with cross-functional teams, the Scientist II generates scientific and technical data to evaluate emerging technologies, advance technology readiness milestones, and support implementation decisions. The role is expected to communicate innovation outcomes, provide data-driven recommendations, and facilitate the transfer of successful technologies into development and manufacturing. Through rigorous experimentation, data analysis, and a commitment to continuous improvement, the Scientist II helps deliver robust, scalable, and innovative solutions across cell and gene therapy platforms. **Key Responsibilities** - Execute lentiviral vector (LVV) downstream process development activities, including the design, optimization, and scale-up of purification processes utilizing chromatography-based and alternative separation technologies. Responsibilities include hands-on development of capture and polishing strategies employing affinity, ion exchange, size-exclusion, hydrophobic interaction, membrane chromatography, and other purification approaches to improve vector recovery, purity, scalability, and manufacturability. - Develop and execute proof-of-concept, feasibility, and characterization studies to assess new technologies and generate data-driven recommendations for further development, implementation, or discontinuation. - Design and perform laboratory studies to evaluate emerging manufacturing, analytical, and characterization technologies that improve process understanding, product quality, manufacturing efficiency, scalability, and robustness across cell and gene therapy platforms. - Support the implementation and integration of new technologies into development and manufacturing workflows by coordinating cross-functional activities, establishing success criteria, managing technical risks, and facilitating knowledge transfer to operational teams. - Draft and review experimental protocols with cross-functional stakeholders, execute studies, and communicate results through technical reports, presentations, and data-driven recommendations. - Maintain Innovation laboratory operations, including equipment management, material procurement, laboratory organization, and coordination of facility and utility requirements to support ongoing projects. - Make decisions related to the planning, execution, and prioritization of assigned technical activities and project deliverables. You are expected to independently manage day-to-day work and recommend solutions based on data and technical judgment. Higher-level approvals are required for significant changes to project scope, technical strategy, methodologies, resource commitments, or cross-functional initiatives that may impact organizational objectives. **Requirements** - Ph.D. in Biology, Biomedical Engineering, Virology, Immunology, or a related field with 0-3 years of relevant experience preferred. Candidates holding an M.S. or B.S. degree with a commensurate combination of additional industry, research, or technical experience that demonstrates equivalent qualifications will also be considered. - Strong hands-on experience with key manufacturing unit operations, including stirred-tank bioreactor operation, TFF, sterile filtration, and chromatography, for biologics or advanced therapy products. - Prior experience with lentiviral vector (LVV) processes and associated analytical tools is desirable but not required.. - Familiarity with artificial intelligence (AI), machine learning (ML), and other data-driven approaches, with experience applying these technologies to bioprocess development, analytical characterization, manufacturing innovation, and gene therapy manufacturing platforms considered a plus - Strong understanding of viral vector manufacturing processes, gene delivery technologies, associated analytical methodologies, and molecular biology techniques, with the ability to apply this knowledge to cell and gene therapy process, product, and analytical development. - Exposure to or experience with biophysical and analytical characterization methodologies, including HPLC, UHPLC, LC-MS/MS, Raman spectroscopy, and related techniques used to assess product quality, process performance, and critical quality attributes, is desirable but not required. - Advanced Proficiency of Microsoft applications (e.g. Word, Excel, PowerPoint) - Experience utilizing biostatistical tools and experimental design methodologies, including JMP (DoE), and GraphPad Prism, to support process optimization, technology development, and data interpretation. - Language(s):English required; Mandarin is a plus. #Li-RP1 #Li-Onsite 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. Pay Range (Base Pay): $110,706—$145,303 USD **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. For information related to our privacy notice, please review: [Legend Biotech Privacy Notice](https://legendbiotech.com/privacy-notice/).