Our Opportunity...

We are seeking a highly motivated Senior Engineer, MSAT to support manufacturing of critical materials for our engineered autologous cell therapies. This role will serve as the technical bridge between development and external manufacturing for the retroviral vector and feeder cell process, responsible for ensuring that the processes run by CDMOs are sufficiently understood, controlled, reproducible, comparable, validated, and technically defensible for regulatory approval.  

This hire will oversee technology transfer, drive risk assessments, operating ranges, and control strategies. They will lead cross-functional efforts with Process Development, Analytical Development, Quality, External Manufacturing, and external CDMO partners to support manufacturing investigations and ensure readiness for PPQ and future commercial manufacturing. 

 As a member of our Technical Operations Group, 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 Hybrid role based out of our Bedford, MA location, requiring travel up to 25–30% to support CDMO activities and occasional after-hours or weekend oversight of ongoing manufacturing runs as needed. 

You Will...

Core responsibilities

• Serve as a technical contributor and developing Subject Matter Expert (SME) for gamma-retroviral vector and feeder cell manufacturing activities supporting production of OBX-115, working closely with cross-functional teams. 
• Support and lead defined workstreams for technology transfer of manufacturing processes to CDMOs, including transfer of process knowledge, critical process parameters, control strategy elements, methods, and manufacturing documentation. Partner with Scientists or Engineers to ensure successful and reproducible execution at receiving sites. 
• Serve as Person-in-Plant (PIP), as needed, at CDMO facilities to support training, technology transfer, investigations, process monitoring, and execution of 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 the Principal /Senior Scientists or Engineers and cross-functional SMEs to establish scientific understanding and appropriate follow-up. 
• Support change controls, process improvements and validation activities by providing technical assessments and process knowledge. 
• Lead and support technical investigations, as appropriate, for deviations, process excursions, atypical results, and manufacturing failures in partnership with Manufacturing Process Development, Quality, and CDMOs. 
• Leverage process knowledge and analytical data to support scientifically sound root-cause investigations and development of appropriate corrective or preventive actions. 
• Support process validation and PPQ readiness and execution, including development/review of protocols, assessment of manufacturing readiness, evaluation of process performance, and on-site technical support.  
• Develop and maintain FMEAs to evaluate process risks and contribute to development and implementation of the manufacturing control strategy, translating process-characterization and manufacturing knowledge into appropriate 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 establishment of post-approval process monitoring and lifecycle-management activities, including continued process verification, trending, and evaluation of manufacturing performance. 

You Bring...

Core Qualifications

• 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, preferably gamma-retroviral vector production using stable producer cell lines and adherent cell culture systems. 
• 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 (SIPOC, HAZOP) and root cause analysis (fishbone/Ishikawa); familiarity with feeder cell manufacturing is highly desirable. 
• Extensive experience in analyzing and 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 judgement to elevate issues for awareness and/or action as needed. 
• Strong technical writing skills. 
• Excellent oral, written, and visual communication skills. You listen to understand and communicate effectively and persuasively with partners, colleagues, and leadership.    
• Collaborative – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes   
• Self-motivated and accountable - proven ability to take initiative, 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

• Prior experience working with TIL or T cells
• Prior experience supporting first commercial launch