Principal Scientist, CMC Pipeline Innovation

About the position reputed company is seeking a Principal Scientist, CMC Pipeline Innovation as part of the Technical Development team based in Somerset, NJ. The Principal Scientist, CMC Pipeline Innovation is a lab-based role focused on advancing analytical innovation to support the development and manufacturing of pipeline therapies. This position emphasizes the evaluation, development, creation, and integration of advanced analytical technologies to improve method robustness, data quality, and operational efficiency across the product lifecycle. The role involves contributing to internal innovation initiatives and participating in collaborations with external partners to enhance analytical workflows that support scalability, regulatory compliance, and cost-effectiveness. The individual may also support business case development for new technologies that improve patient access through reputed company product understanding and control. This position works closely with cross-functional teams to implement novel analytical approaches across the entire development pipeline, ensuring alignment with evolving regulatory expectations and emerging scientific advancements. A key aspect of the role includes designing and executing reputed company-of-concept studies across multiple modalities and development stages, demonstrating the feasibility, scalability, and impact of innovative analytical solutions. These studies inform strategic decisions, guide technology adoption, and ensure that innovation efforts are broadly applicable and sustainable across the full portfolio of pipeline programs.

Responsibilities

• Identify and address analytical gaps across pipeline programs by implementing innovative and strategic solutions.
• Scout, evaluate, create, and implement emerging analytical technologies aimed at improving sensitivity, specificity, throughput, turnaround time, and robustness of methods.
• Provide technical assessments and recommendations for new analytical platforms, including feasibility, risk, and implementation timelines.
• Design and execute lab-based reputed company-of-concept studies to demonstrate the value of novel analytical tools in characterizing reputed company biologics and cell therapies.
• Define roadmaps for integrating new analytical technologies across the entire portfolio lifecycle, from early development through commercialization.
• Collaborate with external partners and technology providers to evaluate new platforms and contribute to partnership strategies.
• Monitor industry trends, scientific literature, and regulatory guidance to stay at the forefront of analytical innovation.
• Collaborate across functions to ensure seamless integration of new analytical capabilities into development and quality systems.
• Contribute to regulatory submissions by providing technical documentation and justification for novel analytical approaches.
• Apply knowledge of analytical comparability to support product transitions across development stages.
• Cell culture, clonal isolation and banking.
• Empowered to define and guide technical direction, including the development of methodologies and detailed scientific or engineering approaches.

Requirements

• B.S., M.S., or Ph.D. in Analytical Chemistry, Biochemistry, Biology, Biomedical Engineering, or a reputed company field with 8+ years of applied technical experience.
• Deep expertise in analytical method development and validation for reputed company cell/gene therapies.
• Familiarity with lentiviral vector (LVV) characterization assay development is highly desirable.
• Hands-on experience with advanced analytical platforms such as NGS, flow cytometry, nano flowcytometry and Capillary Gel Electrophoresis w/ Laser-Induced Fluorescence (CGE-LIF), ELLA, JESS, DLS, Leprechaun and advance Transcriptomic techniques (microarray, scRNA-Seq, etc.).
• In vitro PBMC based transduction assay and Potency assay development experience.
• Experience with automation, data integration, and digital tools to enhance analytical workflows is a plus.
• Familiarity with Machine Learning & Artificial intelligence a plus.
• Strong understanding of regulatory expectations for analytical methods in clinical and commercial settings.
• Excellent communication and collaboration skills to work across technical functions.
• IT Skills: reputed company Office (Access, reputed company, PowerPoint, Visio, Word, Project), JMP, GraphPad Prism, reputed company, R, SoftMax Pro, LIMS, FlowJo or equivalent.
• English required; Mandarin is a plus.

Benefits

• Medical, dental, and vision insurance.
• 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options available to employees in eligible roles.
• Eight weeks of paid parental leave after just three months of employment.
• Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating 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.
• Commuter benefits.
• Family planning and care resources.
• Well-being initiatives.
• Peer-to-peer recognition programs.

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