Senior Engineer, MSAT

Obsidian Therapeutics

. Serve as a technical contributor and developing Subject Matter Expert for gamma-retroviral vector and feeder cell manufacturing activities supporting production of OBX-115 .

Posted 10/20/2026full-timeBedford • Massachusetts • United StatesSenior💰 $81,000 - $99,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in viral vector manufacturing, particularly gamma-retroviral vector production, with a strong focus on process validation, risk assessment, and regulatory compliance. Proven ability to lead technology transfer initiatives and collaborate effectively with cross-functional teams in a biopharmaceutical environment.

Highest-signal resume keywords

Viral Vector ManufacturingProcess ValidationTechnical WritingStatistical Software (JMP, Minitab)Regulatory Submissions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Gamma-Retroviral Vector ProductionAseptic ProcessingFMEA DevelopmentRoot Cause AnalysisProcess MonitoringChange ControlManufacturing DocumentationProcess Performance EvaluationTechnical AssessmentsProcess Knowledge Transfer

Soft Skills

CollaborationCommunicationInitiativeAdaptabilityTime Management

Industry Keywords

Biopharmaceutical IndustryCell TherapyGene TherapyCGMP RequirementsFDA GuidanceEMA GuidanceManufacturing SciencesProcess DevelopmentMSATCritical Process Parameters

About the role

Key responsibilities & impact

Serve as a technical contributor and developing Subject Matter Expert for gamma-retroviral vector and feeder cell manufacturing activities supporting production of OBX-115
Support and lead technology-transfer workstreams for manufacturing processes to CDMOs, including transfer of process knowledge, critical process parameters, control strategy elements, methods, and manufacturing documentation
Serve as Person-in-Plant at CDMO facilities as needed for training, technology transfer, investigations, process monitoring, and critical manufacturing activities
Develop working relationships with CDMO technical and manufacturing teams
Analyze manufacturing and process-monitoring data, identify trends and atypical observations, and 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 for deviations, process excursions, atypical results, and manufacturing failures
Support scientifically sound root-cause investigations and corrective or preventive actions
Support process validation and PPQ readiness and execution, including protocols, manufacturing-readiness assessments, process-performance evaluation, and on-site technical support
Develop and maintain FMEAs 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 CMC regulatory documentation
Support post-approval process monitoring and lifecycle-management activities, including continued process verification, trending, and manufacturing-performance evaluation

Requirements

What you’ll need

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)
Extensive experience analyzing and interpreting manufacturing process data using statistical software such as JMP or Minitab
Experience managing CDMOs
Familiarity with FDA and EMA guidance documents relevant to cell and gene therapy
Strong technical writing skills
Excellent oral, written, and visual communication skills
Ability to collaborate and work effectively with partners, colleagues, and leadership
Ability to take initiative, meet objectives and timelines, and manage multiple responsibilities in parallel
Ability to adapt to change in a fast-paced, rapidly developing environment
Ability to seek and welcome input and continuously learn
Ability to deliver on commitments and operate with urgency

Benefits

Comp & perks

Annual incentive bonus as a percentage of actual base salary
Employee stock options
Comprehensive medical, dental, and vision coverage
Company contributions to health savings and retirement accounts
Ample paid time off
Access to wellness programs
Rich career growth opportunities
Highly collaborative culture
Potential for ownership through stock options