Scientist/Senior Scientist, Viral Vector Analytical Development

You will partner closely with the Quality Control team and external testing laboratories to support method transfer and validation readiness while driving certain internal analytical development efforts. The successful candidate will work collaboratively across Analytical Development, Manufacturing, Process Development, Regulatory, Quality, and external partners to lead analytical development studies, apply statistical approaches to method development and comparability assessments, and provide technical expertise for assay transfer and lifecycle management.

Core Responsibilities

• Lead the development, optimization, troubleshooting, transfer, and lifecycle management of analytical methods for retroviral vectors, ensuring methods are fit-for-purpose for late-stage clinical and future commercial manufacturing.
• Design and execute analytical development studies to evaluate method performance characteristics including accuracy, precision, linearity, range, robustness, comparability, and method capability using sound statistical approaches.
• Analyze and interpret complex datasets using JMP and other statistical tools to support assay development, comparability assessments, method characterization, and lifecycle management.
• Partner closely with Quality Control and external testing laboratories as the analytical development subject matter expert during method transfer, qualification, and validation activities, supporting protocol development, acceptance criteria justification, data review, troubleshooting, and resolution of technical issues.
• Support review and authoring of assay qualification and validation protocols, data analyses and technical reports.
• Support critical reagent qualification and controls, trending of analytical performance data.
• Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.
• Collaborate effectively with Process Development, Quality Control, Research, Quality, Regulatory, Program Management and CDMOs/CTLs to advance analytical strategies supporting viral vector manufacturing and commercialization.
• Source and evaluate new analytical technologies to expand internal technical capabilities and improve assay performance.

Core Qualifications

• PhD in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field).
• Prior experience with retroviral and/or lentiviral vector assays with a progressive track record of leadership and impact.
• Demonstrated experience as a technical leader of analytical development, troubleshooting, technology transfer, and qualification of viral vector assays, with experience supporting validation activities for Phase 3 and/or commercial cell and gene therapy programs.
• Subject matter expertise in methods relevant to viral vector (including cell-based potency assays, titration assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD).
• Strong organization and record keeping skills.
• Experience working with viral vector CDMOs and contract testing laboratories to support method development, transfer, qualification, and validation activities.
• Working knowledge of cGMP and quality systems requirements.
• A desire and ability to work in an entrepreneurial, collaborative environment building healthy, productive, and high trust relationships within your function and with direct stakeholders to effectively influence actions and decisions.
• Scientifically rigorous in designing and executing experiments and record keeping.
• Excellent planning, coordination, and time management skills.
• Ability to manage multiple responsibilities in parallel with minimal direction.
• Excellent oral, written, and visual communication skills.
• Ability to build and maintain productive relationships with department management, peers, and other colleagues across the organization.
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes.
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.
• Flexible - adapts to change in a fast paced, rapidly developing environment.
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner.
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency.

Bonus Qualifications

• A track record with analytical development and method validation for characterization of engineered cell therapies.
• Experience with cell line/primary cell transduction/transfection, cytotoxicity assays, Next Generation Sequencing.
• Hands-on proficiency with JMP for statistical analysis of analytical development, validation, and comparability datasets.
• Experience with Design of Experiment (DOE) approaches and application to analytical development.