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Salary: USD 130,500 - 180,500 / annual
Obsidian Therapeutics is seeking an experienced Scientist or Senior Scientist to lead analytical development efforts for viral vectors supporting late-stage clinical development and commercial readiness of engineered cell and gene therapies. The company's lead program, amsoki-cel (OBX-115), is a novel tumor-infiltrating lymphocyte (TIL) cell therapy using the proprietary cytoDRiVE® platform, currently in clinical development for metastatic melanoma and non-small cell lung cancer.
This is a lab-based role on-site in Bedford, MA with flexibility for hybrid work on non-lab activities. You will serve as both a technical leader and hands-on scientist within the Technical Operations group, driving the development, optimization, troubleshooting, transfer, and lifecycle management of analytical methods for retroviral vectors.
Key responsibilities include:
- Lead development and optimization of analytical methods for retroviral vectors, ensuring fitness-for-purpose for late-stage clinical and commercial manufacturing
- Design and execute analytical development studies evaluating method performance (accuracy, precision, linearity, range, robustness, comparability) using sound statistical approaches
- Analyze complex datasets using JMP and other statistical tools to support assay development, comparability assessments, and lifecycle management
- Partner with Quality Control and external testing laboratories as the analytical development subject matter expert during method transfer, qualification, and validation
- Support protocol development, acceptance criteria justification, data review, and troubleshooting of technical issues
- Author and review assay qualification/validation protocols, technical reports, SOPs, and test methods
- Support critical reagent qualification, controls, and trending of analytical performance data
- Collaborate across Process Development, Quality, Research, Regulatory, and external CDMOs/CTLs to advance analytical strategies
- Source and evaluate new analytical technologies to expand internal capabilities and improve assay performance
You will work in a highly collaborative, entrepreneurial environment with field-leading advisors, best-in-class partners, and an experienced team. The role offers competitive salary, annual incentive bonus, long-term stock options, comprehensive benefits (medical, dental, vision, HSA/401k contributions, paid time off), and career growth opportunities.
REQUIREMENTS:
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 vectors, including cell-based potency assays, titration assays, PCR/qPCR, ddPCR, sequencing, ELISA, and 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
- Working knowledge of cGMP and quality systems requirements
- Ability to work in an entrepreneurial, collaborative environment; builds healthy, productive, high-trust relationships; effectively influences actions and decisions
- Open to input and expertise of others; continuous learner
- Tenacious and resilient; not easily overwhelmed by challenges; delivers on commitments; operates with urgency
Bonus Qualifications:
- 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
