Job Description
**Key Responsibilities:**
Global Process Stewardship
- Own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
- Conduct global change control impact assessments to ensure process consistency across the network
- Support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization
Project Leadership & Strategic Execution
- Lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
- Contribute to Global MSAT project portfolio strategy, prioritization, and execution
- Drive cross-functional alignment and ensure reliable execution of network-level initiatives
Operational Excellence & Process Consistency
- Lead global investigations across sites to identify root causes and implement sustainable solutions
- Develop and implement standard investigation frameworks and playbooks
- Ensure adherence to global governance and change management processes to support process harmonization
Network Integration & Cross-Site Support
- Act as a site-agnostic process expert, supporting alignment of site activities with network strategy
- Partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
- Support process harmonization and implementation of best practices across sites
**Core Competencies:**
- Technical depth & process expertise in late-stage clinical and commercial T cell and viral vector manufacturing
- Leadership without authority across a matrixed, global organization
- Ability to establish business processes, drive standardization and governance in complex environments
- Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy
- Ability to establish business processes, drive standardization and governance in complex environments
**Basic Qualificaitons:**
- Bachelor's Degree in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 8 years of relevant experience
OR
- Masters in Engineering, Biotechnology or Life Sciences with the following years of experience in pharmaceutical/biotech manufacturing, process development or process engineering with at least 6 years of relevant experience
**Preferred Qualifications:**
- Expertise in process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
- Expertise in viral vector manufacturing is a plus
- Cell culture, cell therapy or aseptic processing experience
- Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
- Experience in Project Management and Project Management Methodology
- Strong understanding of GMP environment and change control processes
- Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)
- Proactive and willing to accept temporary responsibilities outside of initial job description
- Experience in engineering in highly regulated manufacturing environments
