Senior Engineer, MSAT

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.

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 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.
• 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