Key Responsibilities Strategic Leadership & Technical Oversight
- Drive the MSTG strategy for injectable manufacturing, aligning with corporate goals and regulatory expectations.
- Lead cross-functional teams in the design, development, and optimization of manufacturing processes.
- Provide technical leadership during product lifecycle stages including development, scale-up, commercialization, and post-launch support.
Technology Transfer & Commercialization
- Oversee complex technology transfer projects across multiple sites or products.
- Ensure readiness of manufacturing sites for new product introductions through robust planning and execution.
- Collaborate with R&D, Regulatory Affairs, and Global Technical Operations to ensure successful commercialization.
Process Validation & Compliance
- Lead the design and execution of process validation strategies including PPQ, cleaning validation, and lifecycle management.
- Ensure compliance with global regulatory standards (USFDA, EU, WHO, PIC/S) and internal quality systems.
- Represent MSTG during regulatory inspections and audits, providing expert technical support.
Operational Excellence & Innovation
- Champion continuous improvement initiatives using QbD, Six Sigma, and Lean methodologies.
- Evaluate and implement advanced technologies (PAT, automation, digital tools) to enhance process robustness and efficiency.
- Monitor industry trends and regulatory changes to proactively adapt manufacturing strategies.
Team Development & Stakeholder Engagement
- Build and mentor a high-performing MSTG team, fostering a culture of technical excellence and accountability.
- Engage with senior leadership, cross-functional teams, and external partners to drive strategic initiatives.
- Develop and deliver technical training programs for manufacturing and quality teams.
