Senior Engineer, MSAT

Obsidian Therapeutics•Bedford, MA

2d•$81,000 - $99,000•Hybrid

About The Position

Obsidian Therapeutics is seeking a highly motivated Senior Engineer, MSAT to support manufacturing of critical materials for engineered autologous cell therapies. The role serves as a technical bridge between development and external manufacturing for retroviral vector and feeder cell processes, helping ensure CDMO-run processes are understood, controlled, reproducible, comparable, validated, and technically defensible for regulatory approval. The position oversees technology transfer and drives risk assessments, operating ranges, and control strategies. It leads cross-functional work with Process Development, Analytical Development, Quality, External Manufacturing, and CDMO partners to support manufacturing investigations and readiness for PPQ and future commercial manufacturing. As part of the Technical Operations Group, the role supports the company’s lead program, amsoki-cel (OBX-115), an engineered tumor-infiltrating lymphocyte cell therapy using the cytoDRiVE® platform. This is a hybrid role based in Bedford, Massachusetts, requiring travel up to 25–30% to support CDMO activities and occasional after-hours or weekend oversight of manufacturing runs as needed.

Requirements

M.S. or B.S. in Chemical Engineering, Bioengineering, Biotechnology, Cell Biology, Virology, Immunology, Biochemistry, or a related scientific discipline.
10+ years of relevant biopharmaceutical industry experience in MSAT, Process Development, Viral Vector Development, Cell Therapy, Gene Therapy, or related manufacturing sciences.
Technical expertise in viral vector manufacturing; gamma-retroviral vector production using stable producer cell lines and adherent cell culture systems is preferred.
Strong understanding of aseptic processing and cGMP requirements and their application to viral vector and mammalian cell culture manufacturing.
Demonstrated experience supporting PPQ, process validation, regulatory submissions, and commercialization readiness.
Experience developing FMEAs and process risk assessments such as SIPOC and HAZOP, and root-cause analysis such as fishbone/Ishikawa.
Extensive experience analyzing and interpreting manufacturing process data using statistical software such as JMP or Minitab.
Scientific rigor to enable data-driven decisions.
Experience managing CDMOs.
Familiarity with FDA and EMA guidance documents relevant to cell and gene therapy.
Confidence and good judgment to elevate issues for awareness or action as needed.
Strong technical writing skills.
Excellent oral, written, and visual communication skills, including the ability to listen and communicate effectively and persuasively with partners, colleagues, and leadership.
Collaborative approach, with a recognition that success requires teamwork and interdisciplinary thinking and a willingness to share feedback and ideas.
Self-motivated and accountable, with the ability to take initiative, meet objectives and timelines, maintain high standards, and manage multiple responsibilities in parallel.
Ability to adapt to change in a fast-paced, rapidly developing environment.
Curiosity, humility, willingness to seek and welcome others’ input and expertise, and commitment to continuous learning.
Tenacity and resilience, including the ability to deliver on commitments and operate with urgency.

Nice To Haves

Familiarity with feeder cell manufacturing.
Prior experience working with TIL or T cells.
Prior experience supporting a first commercial launch.

Responsibilities

Serve as a technical contributor and developing subject matter expert for gamma-retroviral vector and feeder cell manufacturing supporting OBX-115.
Support and lead defined workstreams for technology transfer to CDMOs, including transfer of process knowledge, critical process parameters, control strategy elements, methods, and manufacturing documentation.
Partner with scientists or engineers to support successful, reproducible execution at receiving sites.
Serve as Person-in-Plant at CDMO facilities as needed to support training, technology transfer, investigations, process monitoring, and critical manufacturing activities.
Develop effective working relationships with CDMO technical and manufacturing teams.
Analyze manufacturing and process-monitoring data, identify trends and atypical observations, and work with senior colleagues and cross-functional subject matter experts to establish scientific understanding and follow-up.
Support change controls, process improvements, and validation activities through technical assessments and process knowledge.
Lead and support technical investigations into deviations, process excursions, atypical results, and manufacturing failures in partnership with Manufacturing Process Development, Quality, and CDMOs.
Use process knowledge and analytical data to support scientifically sound root-cause investigations and appropriate corrective or preventive actions.
Support process validation and PPQ readiness and execution, including protocol development or review, manufacturing-readiness assessment, process-performance evaluation, and on-site technical support.
Develop and maintain FMEAs to evaluate process risks and contribute to manufacturing control strategy, process controls, monitoring approaches, and risk-management activities.
Author and review protocols, technical reports, investigations, risk assessments, validation-support documentation, and relevant portions of CMC regulatory documentation.
Support post-approval process monitoring and lifecycle-management activities, including continued process verification, trending, and evaluation of manufacturing performance.