Scientist/Senior Scientist, Viral Vector Analytical Development

The role

This person will lead the development, optimization, troubleshooting, transfer, and lifecycle management of analytical methods for retroviral vectors. They will support late-stage clinical development and commercial readiness for autologous cell therapy programs.

What you will do

• Lead development, optimization, troubleshooting, transfer, and lifecycle management of analytical methods for retroviral vectors.
• Design and execute analytical development studies using statistical approaches.
• Analyze and interpret complex datasets using JMP and other statistical tools.
• Partner with Quality Control and external testing laboratories for method transfer, qualification, and validation.
• Support review and authoring of assay qualification and validation protocols, data analyses, and technical reports.
• Support critical reagent qualification and controls and trending of analytical performance data.
• Author and review technical and scientific documents including study protocols, reports, validation documents, SOPs, and test methods.
• Collaborate with Process Development, Quality Control, Research, Quality, Regulatory, Program Management and CDMOs/CTLs.
• Source and evaluate new analytical technologies.

Required 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.
• Demonstrated experience as a technical leader of analytical development, troubleshooting, technology transfer, and qualification of viral vector assays.
• 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.
• Working knowledge of cGMP and quality systems requirements.
• Ability to manage multiple responsibilities in parallel with minimal direction.
• Excellent oral, written, and visual communication skills.

Nice to have

• 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.

Benefits

• Annual incentive bonus
• Employee stock options
• Comprehensive medical, dental, and vision coverage
• Company contributions to health savings and retirement accounts
• Ample paid time off
• Access to wellness programs
• Rich career growth opportunities

About the company

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Their lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.