Head – MSAT; Injectables

Position: Head – MSAT (Injectables)
Location: Nālāgarh

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