Manager, Manufacturing Injectables

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.