Job Purpose
To lead MSAT activities for sterile injectable products including technology transfer, scale-up, exhibit batches, process optimization, product launch, and commercial readiness while ensuring compliance with cGMP, regulatory requirements, and organizational objectives.
Key Responsibilities
MSAT & Technology Transfer
- Lead technology transfer, scale-up (SU), exhibit batch (EB), and commercial launch activities for injectable products.
- Coordinate with customers/business partners for project execution and launch timelines.
- Drive cross-functional coordination with Production, QA, QC, Regulatory, Engineering, SCM, and Procurement teams.
- Ensure execution readiness for product launches and tech transfer activities.
- Coordinate analytical method transfer for APIs and drug products at manufacturing sites.
- Support process validation, commercial batches, and troubleshooting activities.
- Monitor project timelines and provide regular updates to management and stakeholders.
- Ensure compliance with cGMP, Quality Systems, and regulatory expectations during project execution.
- Review technical/quality agreements and related project documentation.
Formulation & Development
- Lead the Formulation & Development team for sterile injectable products.
- Conduct literature review, RLD characterization, and formulation feasibility assessment.
- Drive formulation and process optimization activities.
- Review stability data, development reports, and technical documentation.
- Optimize lyophilization cycles, filter validation, and terminal sterilization processes.
- Finalize specifications for APIs, excipients, and finished products.
- Prepare and review technical documents including MFR, BOM, stability protocols, and validation documents.
- Execute scale-up, exhibit, registration, and validation batches.
Qualifications
- M.Pharm / PhD in Pharmaceutics or related discipline.
Experience
- 15–18 years of experience in sterile injectable manufacturing, MSAT, formulation development, and technology transfer.
- Strong exposure to aseptic processing, lyophilization, terminal sterilization, and regulatory requirements.
Key Skills
- MSAT & Technology Transfer
- Sterile Injectable Development
- cGMP & Regulatory Compliance
- Project & Stakeholder Management
- Process Optimization & Validation
- Technical Documentation
- Cross-functional Coordination
- Leadership & Team Management
