Role & responsibilities

Purpose To drive the effective, scientific, and compliant transfer of current products from R&D;/Formulation & Development (F&D;) to the commercial manufacturing plant. This role ensures total operational and documentation readinessincluding material tracking, process scale-up calculations, validation support, and QMS compliance—to establish robust commercial-scale manufacturing in accordance with cGMP and regulatory guidelines.

Responsibilities

- Technical Documentation & Material Readiness: Review product development files, process flows, and technical parameters received from F&D; to author comprehensive tech transfer protocols, checklists, manufacturing instructions, and raw material/packing material Bill of Materials (BOM).
- Systems & Inventory Coordination: Create documentation categories in SAMWED for scale-up, exhibit, and validation batches while actively monitoring RM/PM tracking plans to ensure continuous material availability.
- Process Parameter Transfer: Ensure the seamless transfer of Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), process controls, and safety precautions from development scale to the commercial floor.
- Batch Execution & Monitoring: Perform rigorous scale-up calculations for formulations, batch sizes, equipment capacities, and material quantities while providing direct shop-floor monitoring during scale-up, exhibit, and process validation batches.
- Data Evaluation & Yield Assessment: Review batch execution data, processing times, yields,



and machine performance to identify critical gaps or engineering challenges between pilot scale and commercial production.
- Cross-Functional Interface: Act as the central point of contact between R&D;, F&D;, Production, QA, QC, Warehouse, and Engineering to streamline production scheduling and technical alignment.
- Technical Troubleshooting: Coordinate cross-functionally to investigate process deviations, yield discrepancies, and mechanical bottlenecks encountered during batch execution, providing technical recommendations for yield and productivity optimization.
- QMS Compliance: Initiate, investigate, and handle QMS workflows related to technology transfer, including Change Controls, Deviations, Risk Assessments, CAPA designs, and effectiveness checks.
- Regulatory Audit Support: Provide technical assessment, data compilation, and dossier support to prepare high-quality responses for regulatory queries (USFDA, MHRA, etc.) related to manufacturing validation and product performance.
- Operational Adaptability: Step onto the manufacturing floor to execute trials, support engineering adjustments, and work flexibly across all rotational shifts based on product execution priorities.

Required Skills

- Solid Oral Unit Operations: Strong scientific understanding of manufacturing unit operations including Granulation (wet/dry),



Blending, Compression, Coating, and Capsulation.
- Scale-Up Calculations: Proficient in determining material quantities, process yields, processing parameters, and equipment capacities using data-driven scale-up principles.
- QMS & Documentation Literacy: Sound basic knowledge of internal quality management systems, change control logging, deviation reporting, and formal risk evaluation (QRM).
- Technical Report Writing: Ability to compile floor observations and complex lab data into clean, compliant validation protocols and final summary reports.
- Cross-Functional Communication: Good written and verbal communication skills required to mediate technical parameters smoothly between R&D; scientists and plant floor executives.

Preferred Candidate Details

- Core Academic Background: Must possess an M.Pharm degree specializing in Pharmaceutics from an accredited institution.
- Industry Focus: 3 to 7 years of dedicated experience managing tech transfer or product development trials strictly within a regulated Pharmaceutical Formulation (OSD) manufacturing site.
- Audit Exposure: General familiarity with the documentation standards and inspection expectations required to face major regulatory bodies (USFDA / MHRA).
- Shift Availability: Mandatory readiness to operate across all operational shifts based on site layout scheduling and target batch execution timelines.
- System Familiarity: Familiarity with digital content/document repositories (like SAMWED) or standard pharma ERP tools is highly preferred.

📌 Walk-in Interview For Officer / Executive - Tech Transfer (OSD) (Pithampur)
🏢 Rubicon Research
📍 Pithampur