Hiring For Senior Level- MSTG

Job Purpose

To lead strategic initiatives in process development, technology transfer, and continuous improvement for injectable manufacturing. The role ensures robust, compliant, and efficient manufacturing processes aligned with global regulatory expectations and business goals.

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.

Qualifications & Experience

M.Pharm / M.Sc. / B.Tech / M.Tech in Pharmaceutical Sciences, or related discipline.
1218 years of experience in sterile/injectable manufacturing, with significant exposure to MSTG, technical services, or process development. Proven track record in leading technology transfers, process validations, and regulatory inspections.

Key Competencies

Strong leadership and project management skills.

Deep understanding of aseptic processing, lyophilization, and cleanroom operations.

Expertise in regulatory compliance and documentation.

Analytical mindset with proficiency in statistical tools (e.g., Minitab, JMP).

Excellent communication, stakeholder management, and decision-making abilities.

interested candidate can share CV @

bhuvneshwari.rathore@amneal.com

Subject Line : CV for MSTG