Job Description

About the Role

To lead and govern operational and strategic manufacturing process technology transfer of sterile dosage formulations (PFS, Cartridges, Vials, Ophthalmic) from DDRL to Receiving Units (RUs) and CMOs. Ensure seamless scale-up, exhibit execution, and commercial validation adhering to project timelines, budget, cGMP, GDP, and global quality standards. Drive team performance, cross-functional alignment, and technical risk mitigation across all sterile transfer projects.

Responsibilities

1. Assessment & Feasibility Oversight

Lead assessment, batch planning, equipment capability evaluation, and chain matching across RUs and CMOs.
Ensure site readiness, including test licenses, cleaning validations, SAP codes, and RM/PPM vendor qualifications.
Ensure RM/PPM procurement, change controls, and assessment batch documentation (BMRs, Sampling Plans) as applicable.
Evaluate Assessment Batch Reports and determine exhibit/submission batch strategies.
Undertake preparation of Quality Risk Assessments (QRA) and Failure Mode, Effects, and Criticality Analysis (FME(C)A) as systematic, proactive methodologies to identify, evaluate, and prioritize potential risks or failures in processes, designs, or systems before they cause harm or operational breakdown at RUs or CMOs.

2. Exhibit & Regulatory Submission Governance

Drive end-to-end strategy for submission/exhibit batches across internal sites and CMOs.
Review regulatory requirements and equipment constraints to approve target batch sizes and process parameters.
Troubleshoot concerns encountered in assessment and / or exhibit manufacturing, OOS, and stability trends.
Review Process Validation Reports, Hold Time Study Reports, and propose commercial batch size proposals based on sales forecasts.

3. Commercial Launch Validation & Scale-Up

Review commercial validation protocols (PPQP) and BMRs aligned with RA packages and exhibit data.
Provide technical direction during initial commercial validation batches (minimum first 3 batches) to reduce process variability.
Review PPQ reports and authorize Technology Transfer Closing Reports post-Product Quality Reviews (PQR).

4. Process Compliance, Documentation & SOP Governance

Establish SOP systems for cGMP, GDP, and regulatory compliance.
Oversee Scope of Work (SOW) creation for outbound transfers, CMO contracts, and inventory of sterile-specific consumables (filters, tubing).
Approve QRA Addendums, change controls, and major deviation/OOS reports; optimize plant capacity utilization for DDRL products.

5. Team Leadership & Strategy

Mentor and manage team members (Assistant/Deputy Managers) through performance reviews and capability assessments.

Academic Qualifications : M. Pharmacy

Professional Experience and Relevant Skills

Experience: 12–15+ years of relevant experience in Pharmaceutical Technology Transfer, Scale-Up, or Manufacturing of Sterile Dosage Forms.
Technical Leadership & Team Mentorship
Vendor & CMO Management
Cross-functional Project Management & Strategic Planning

Technical Expertise

Deep knowledge of sterile formulation processing (PFS, Cartridges, Vials, Ophthalmic, Aseptic filling, Terminal Sterilization).
Hands-on expertise in scale-up, equipment suitability, process validation (PPQ), hold time, and cleaning validation.
Strong mastery of global regulatory standards (cGMP, USFDA, EMA, MHRA) and Quality Risk Management (QRA/RCA/OOS).

Proficient in SAP systems and tech transfer documentation workflows.