Key Responsibilities
Technical Operations & Process Excellence
- Lead scale-up, engineering batches, PPQ batches, process validation, and technology transfer activities.
- Review and approve validation protocols, reports, and batch manufacturing records.
- Drive process optimization, troubleshooting, revalidation, batch size changes, equipment changes, and alternate vendor development.
- Act as SME for process-related deviations, OOS, CAPA, change controls, and investigations.
- Ensure effective risk assessments and continuous process improvement initiatives.
- Support facility and equipment qualification activities.
Manufacturing Network Strategy & Planning
- Lead capacity planning and RCCP activities to align demand with manufacturing capabilities.
- Identify manufacturing constraints and implement mitigation plans.
- Review forecasts, production schedules, and site commitments to ensure timely product supply.
- Drive production scheduling, resource utilization, and schedule adherence.
- Support new product introductions, site transfer projects, and area change validations.
- Lead implementation and optimization of scheduling and planning systems.
Cross-Functional Leadership
- Collaborate with Production, QA, QC, Supply Chain, Engineering, Regulatory Affairs, and R&D teams.
- Drive successful commercialization and lifecycle management of products.
- Review historical manufacturing and quality data to identify improvement opportunities.
- Monitor project progress and ensure on-time delivery from development to commercial launch.
Team Development & Compliance
- Build and develop a high-performing MSAT team.
- Conduct technical training for Production, IPQA, and cross-functional teams.
- Ensure compliance with cGMP, regulatory requirements, and data integrity standards.
Qualification & Experience
- M.Pharm or equivalent.
- 15+ years of experience in pharmaceutical manufacturing, MSAT, technology transfer, and process validation.
- Strong experience in Solid Oral Dosage manufacturing and regulated markets.
Key Competencies
- Technology Transfer & Commercialization
- Process Validation & Lifecycle Management
- OSD Manufacturing
- Capacity Planning & Manufacturing Strategy
- Quality Risk Management
- Regulatory Compliance
- Project & Stakeholder Management
- Leadership & Team Development
