Scientist II, CMC Pipeline Innovation
About The Position
Legend Biotech is seeking a Scientist II, CMC Pipeline Innovation as part of the Technical Development team based in Somerset, NJ. 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.
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.
- 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.
- 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.
- English required
Nice To Haves
- 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
- 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.
- Mandarin is a plus.
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.
Benefits
- Medical, dental, and vision insurance
- 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
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
