Our Opportunity...

We are looking for an experienced and highly motivated scientist to help advance Obsidian's analytical sciences capabilities in support of late-stage clinical development, commercial readiness, and future BLA filings.

The Scientist/Senior Scientist, Viral Vector Analytical Development is a key role within our Technical Operations group and will serve as both a technical leader and hands-on scientist, contributing to the development, optimization, troubleshooting, transfer, and lifecycle management of analytical methods for viral vectors for our first clinical stage autologous cell therapy program targeting solid tumors.

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.

As a member of our Technical Operations team, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team.

This is a lab-based roleon-site in our Bedford, MA location, with flexibility for a hybrid schedule for certain activities outside of the lab.

You Will...

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.

You Bring...

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. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.
• 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.