Senior Manager Technology Transfer (API)

Location: Vapi

Industry: Pharmaceutical (API / Bulk Drugs)

Experience Required: 1018 Years

Department: Technology Transfer / Technical Operations / Process Engineering

Job Overview

We are seeking an experienced Senior Manager – Technology Transfer (API) to oversee and drive the seamless transfer of Active Pharmaceutical Ingredient (API) products and manufacturing processes from R&D; to pilot scale and full-scale commercial production. The ideal candidate will possess deep technical expertise in chemical scale-up, process optimization, cGMP compliance, and cross-functional coordination across R&D;, Production, QA, QC, and Regulatory Affairs.

Key Responsibilities

- Technology Transfer & Scale-Up: Lead end-to-end technology transfer from bench-scale R&D; to pilot and commercial-scale manufacturing sites.
- Batch Execution: Oversee the successful execution of scale-up batches, trial batches, exhibit batches, and process validation batches.
- Documentation & Review: Prepare, review, and approve comprehensive Tech Transfer Dossiers (TTD), Process Flow Diagrams (PFDs), Master Batch Records (MBRs), Scale-Up Reports, and Risk Assessments.
- Cross-Functional Collaboration: Partner closely with R&D;, Operations, QA, QC, Supply Chain, and Regulatory teams to ensure seamless commercialization aligned with submission timelines.
- Troubleshooting & Problem Solving: Identify and resolve process, yield, equipment capacity,



and manufacturing bottlenecks during scale-up and initial commercial batches.
- Quality & Compliance: Monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Lead deviation investigations, Root Cause Analysis (RCA), and implementation of CAPAs for process-related issues.
- Continuous Improvement: Drive process optimization, yield improvement, cycle time reduction, and process robustness while maintaining strict cGMP compliance.
- Equipment Suitability: Evaluate plant equipment capabilities, occupancy, and engineering requirements for current product introductions (NPIs).

Candidate Profile & Qualifications
- Education: B.Tech / M.Tech in Chemical Engineering, or M.Sc. / Ph.D. in Organic Chemistry / Applied Chemistry.
- Experience: 10 to 18 years of hands-on experience in API Technology Transfer, Process Engineering, Technical Operations, or Process R&D; within the pharmaceutical sector.

- Technical Skills:
- Proven track record in scaling up API processes from lab scale to commercial reactors.
- In-depth understanding of organic synthesis, reaction kinetics, crystallization, isolation, drying, and micronization techniques.
- Expert knowledge of cGMP, ICH guidelines (Q8, Q9, Q10, Q11), process validation, and regulatory requirements.
- Strong skills in root cause investigation tools (e.g., Fishbone, 5-Why, FMEA).
- Soft Skills: Excellent leadership, project management, troubleshooting, and cross-functional communication abilities.

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