Senior Manager, Technical Services

The primary function of the Technical Services Senior Manager is to provide senior technical leadership for Technology Transfer, Product and Process Improvements, Primary Packaging Components, Medical Device Combination Products (MDCP) and Data Analytics. This role leads a team of scientists and engineers responsible for technology transfer of products and product lifecycle management, packaging component lifecycle management, device-related investigations and changes, data-driven defect trending to ensure robust, compliant, and reliable commercial supply.

The position serves as a site Subject Matter Expert (SME) for product processes, statistical process monitoring and primary packaging systems and partners cross-functionally with Manufacturing, Quality, Validation, Supply Chain, Procurement and Global Technical Services to drive continuous improvement, investigation excellence and regulatory compliance.

This position will identify and evaluate new and innovative technology, identify, and develop improved processes for new and existing products and drive critical investigations.

• Lead, coach, and develop a team of scientists and engineers supporting products, processes, MDCPs, process analytics and primary packaging components.
• Set technical direction, prioritize work, allocate resources and manage work performance, development and goal setting.
• Serve as a senior technical mentor and escalation point for complex investigations, deviations, and regulatory-facing issues.

• Provide technical ownership for product technology transfers, and product/process improvements across product lifecycle.
• Serve as SME for:
  Sterile filtration processes, primary components (CCIT), Product E/L, Data Analytics
• Review and approve scientific technical reports in support of Technology Transfers and complex investigations with demonstrated application of black belt tools.

• Provide technical ownership for primary packaging components (e.g., vials, stoppers, seals, syringes, cartridges) across their lifecycle.
• Serve as SME for:
  Packaging component qualifications, Supplier Change Notifications (SCNs) and Supplier Corrective Action Requests (SCARs), packaging related deviations, investigations and root cause analysis
• Interface directly with component suppliers and represent site capabilities in cross-site and global forums.
• Ensure component designs and specifications are compatible with existing and new manufacturing and packaging equipment.

• Provide technical leadership for delivery devices and combination products including syringes and related systems.
• Lead and support device-related investigations and discrepancy resolution with root cause analysis and CAPA development for device failures.
• Manage and assess changes to device components suppliers, or manufacturing processes to ensure regulatory compliance.
• Support device verification, risk assessments, mitigations strategies and risk management plans.
• Partner with internal and external manufacturing sites and third-party vendors to implement changes and support commercial supply.

• Lead statistical trending and monitoring of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Visual inspection and defect data.
• Apply statistical tools to:
  Identify process variability and emerging trends, support investigation hypotheses and root cause determinations, evaluate effectiveness of CAPAs.
• Establish and maintain data-driven approaches to defect reduction, process control and continuous improvement.
• Communicate statistical findings clearly to technical, quality, and leadership stakeholders.