Walk-in Interview For Officer / Executive - Tech Transfer (OSD)

Rubicon Research; Pithampur; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Rubicon Research in India seeks a Tech Transfer Specialist to drive scalable transfer of formulations from R&D to commercial manufacturing. You will ensure CPPs/CQAs are transferred, prepare tech transfer docs, and support QMS compliance and regulatory readiness.

Key focus areas include batch scale-up calculations, documentation readiness, cross-functional coordination, and on-floor support across shifts to meet production timelines.

Qualifications

• Strong understanding of manufacturing unit operations (Granulation, Blending, Compression, Coating, Capsulation).
• Proficient in determining material quantities, yields, parameters, and equipment capacities.
• Knowledge of internal quality management systems, change control, deviations, risk evaluation (QRM).
• Ability to compile floor observations and lab data into validation protocols and final reports.
• Excellent written and verbal communication to mediate technical parameters between R&D and plant floor.

Responsibilities

• Technical Documentation & Material Readiness: Author tech transfer protocols, checklists, manufacturing instructions, BOMs.
• Systems & Inventory Coordination: Create documentation categories in SAMWED for scale-up, exhibit, and validation batches; monitor RM/PM plans.
• Process Parameter Transfer: Ensure seamless CPP/CQA transfer from development to commercial scale.
• Batch Execution & Monitoring: Conduct scale-up calculations and provide on-floor monitoring during scale-up, exhibit, and validation batches.
• Data Evaluation & Yield Assessment: Review batch data, processing times, yields, and machine performance to identify gaps.
• Cross-Functional Interface: Coordinate between R&D, F&D, Production, QA, QC, Warehouse, and Engineering.
• Technical Troubleshooting: Investigate deviations and bottlenecks; provide recommendations to improve yield and productivity.
• QMS Compliance: Manage change controls, deviations, risk assessments, CAPA, and effectiveness checks.
• Regulatory Audit Support: Compile data and dossiers for regulatory queries related to manufacturing validation.
• Operational Adaptability: Work across all shifts to support trials and adjustments on the floor.

Skills

Solid Oral Unit Operations

Scale-Up Calculations

QMS & Documentation Literacy

Technical Report Writing

Cross-Functional Communication

Education

M.Pharm in Pharmaceutics

Tools

SAMWED

Pharma ERP systems

Job description

Role & responsibilities

Purpose

To drive the effective, scientific, and compliant transfer of new 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.