Principal Engineer, Viral Vector Analytical Tech Transfer

This is what you will do:

The position will oversee and lead technical transfer of analytical methods and qualification, to both internal and external contract testing & manufacturing (CTO/CMO) companies. This position is responsible for providing strong scientific leadership, mentorship for junior team members and subject matter expertise including technology transfer, method suitability, qualification and validation, raw material testing and controls and aseptic process assurance/microbiological control. The Principal Engineer will also lead timely risk identification, communication and resolution and work in close collaboration with Process Development and Clinical Supply (PDCS), Alexion Operations, Quality (QA), Regulatory (RA), Analytical Development Quality Control (ADQC) and internal and external Testing/Manufacturing sites.

You will be responsible for:

• Provide technical leadership and oversight of clinical technical transfer methods to internal and/or external manufacturers and ensure alignment with CMC schedule to meet program and corporate goals / metrics, as required. This includes continuous communication with key cross-functional stakeholders to ensure efficient tech transfer of Alexion's clinical viral vector manufacturing activities.
• Lead technical evaluation and contribute to selection of external testing facilities.
• Perform laboratory fit analysis, method gap assessments, and establish control strategy for each new receiving site. Lead efforts to assess readiness for early and/or late phase transfers using appropriate tools and manage risk communication with leadership along with proposed mitigation/s
• Lead creation and/or technical review of method transfer protocols, analytical method SOPs, analytical qualification/validation protocols and/or reports, change controls, and LIRs/deviations to support GMP testing and release throughout lifecycle of viral vector pipeline in partnership with QA and Alexion operations as applicable
• Ensure appropriate data management, perform process monitoring and communicate operation status to management. Provide technical depth and lead OOT and deviation investigations as required
• Serve as Analytical transfer Lead, including representation at CMC asset team, to support late-stage pipeline programs through validation campaigns and initial commercialization, as required. Ensures effective collaboration of all involved functions and external parties
• Lead continuous improvement of efficiency of technology transfer plans and work process and influence manufacturing sites to focus on improving efficiency of technology transfer processes
• Co-author and review IND/IMPD, BLA/MAA and other technical documents for regulatory agency submissions
• Global role requiring domestic and international travel (:20%)
  
  
  

You will need to have:

• PhD in biochemistry, biological science, or chemical engineering or related fields with 4+ years of relevant experience, or BS/MS with 8+years of relevant experience in biopharmaceutical organization with expertise in analytical development, quality control and/or tech transfer
• Requires technical services experience for discrepancy resolution, LIR investigation / resolution, root cause analysis, CAPA implementation and analytical control data monitoring for internal and external facilities
• Experience with development or implementation of AAV viral vector and/or plasmid DNA methods in a development or GxP setting
• Requires strong understanding of technology transfer and clinical phase appropriate process oversight and control, with expertise in late phase technology transfer and validation
• Comprehensive understanding of cGMP/ICH requirements for clinical and commercial biopharmaceuticals
• Ability to present and defend technical aspects of analytical testing and validation during regulatory agency inspections and/or queries
• Strong project leadership and resource management skills along with good people, verbal, and communication skills. Ability to support development of aggressive but achievable project plans to ensure effective, timely execution and lead by influence both internal and external stakeholders.
  
  
  

We would prefer for you to have:

• Knowledge in planning for program advancement to analytical validation and commercial launch, with experience supporting teams through BLA approvals
• Strong knowledge of AAV-specific analytical methods and testing requirements
• Expertise in raw material or microbiological control strategy
• Capability to analyze data using basic statistical methods using tools such as JMP, and present comparability analysis in evidence of effective transfer
• Knowledge of quality attribute measurement assays and application to troubleshooting product quality related discrepancies.
• Structured problem solving experience
• In-person statement for 4 days in the office:
  
  
  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.