Senior Technical Lead
Job Summary
This is an opportunity to step into a senior global technical role supporting a growing portfolio of API external supply projects across the APAC region. You will work at the intersection of API manufacturing, technical operations, external supply, quality and project leadership, partnering with global stakeholders and Contract Manufacturing Organisations (CMOs). You will act as the technical lead for API external supply activities, leading source changes, technical transfers, and complex investigations.
Responsibilities
- Act as technical lead for API external supply activities
- Lead complex CMO investigations and technical transfers
- Drive Cost Improvement Projects and supplier performance
- Manage cross-functional project teams and global stakeholders
Required Skills
- API manufacturing and technical operations
- Chemistry, manufacturing and product-quality assessment
- Risk assessments and FMEA
- Project leadership and stakeholder management
Job Details
Senior Manager – External Supply Technical Lead
API External Supply & Technical Leadership
- Act as the technical lead for API external supply activities, partnering with global Technology & Engineering, Quality, Regulatory, Engineering, manufacturing sites and CMOs.
- Lead API source changes and alternate CMO qualification from technical assessment through implementation.
- Evaluate source-change impacts from a chemistry, manufacturing and product-quality perspective and drive technical solutions.
Complex Technical Investigations
- Lead complex CMO investigations involving API chemistry, processing, analytical challenges and product quality.
- Drive cross-functional investigation teams and ensure corrective actions are implemented against agreed timelines.
- Review manufacturing data, analytical results, specifications, operating instructions and technical reports to identify and resolve technical issues.
Technical Transfers & Process Robustness
- Lead technical transfer and process-change activities while assessing manufacturing risks and process robustness.
- Develop and execute risk assessments, FMEA and API/DP assessments.
- Support API specifications, process validation and technical change-management activities.
- Evaluate specification robustness and develop prioritised strategies to improve process performance.
Cost & Supplier Performance
- Lead Cost Improvement Projects (CIPs) with third-party API manufacturers.
- Partner with CMOs to improve manufacturing performance, quality and cost.
- Provide technical input on supplier performance and identify opportunities for improvement across the external API network.
Global Stakeholder Management
- Build and lead cross-functional project teams, managing project plans, milestones, risks, resources and dependencies.
- Communicate effectively with senior global stakeholders on project progress, technical risks, timelines and supply challenges.
- Engage specialist technical groups and SMEs where additional laboratory or process-development support is required.