F&D - Team Lead

B&S Group; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

B&S Group seeks a formulation transfer professional to coordinate technology transfer across Analytical, Production, QA/QC and Regulatory teams. The role includes reviewing notebooks, SOPs, protocols and specifications to ensure compliant documentation for new product transfers.

The candidate will supervise scale-up/validation batches of solid and liquid dosage forms, identify transfer strategies, and drive process improvements across multiple sites, ensuring GMP alignment and cross-location

Responsibilities

• Coordinate with Analytical, Production, QA, QC, and Regulatory teams for smooth technology transfer of new products.
• Review documents such as laboratory notebooks, SOPs, protocols, reports and specifications.
• Review Master Formula Card, BMR, BPR, Product Detail, scale-up protocol and related docs per Good Documentation Practice for new products.
• Troubleshoot and reformulate solid oral (IR and MR) and liquid oral (solutions and suspensions) dosage forms.
• Conduct GAP analysis with Process Improvement to improve productivity and cross-location equipment equivalency.
• Review batch size formulas (Scale Up/Down) and monitor optimization and validation batches across locations.
• Execute and monitor Optimization/Exhibit/Validation Batches at parent and site locations; review trial batch protocols and reports.

Job description

Job Responsibilities

• To co-ordinate with different departments like Analytical, Production, QA, QC, Regulatory for smooth technology transfer of new products and troubleshooting in existing formulations.
• To review documents (Laboratory notebooks, SOPs, Protocols, Reports and Specification). Scale-up/Optimization/Validation batches execution and monitoring of solid and liquid dosage forms.
• To review literature and patent searches and identify appropriate transfer approach and strategy design to transfer the product.
• Review of documents like Master formula card (MFC), BMR, BPR, Product Detail, Scale up protocol and reports, Raw materials and Product Specifications as per Good Documentation Practice for new products.
• Troubleshooting and reformulate Solid oral (Immediate release and Modified release) and liquid oral (Solution & Suspension) dosage forms which are commercialized or manufactured at other hand.
• Review of batch size formula (Scale Up / Scale Down), GAP analysis with Process Improvement to improve the productivity and Equipment Equivalency Evaluation across all locations.
• Execute and monitor Optimization Batch / Exhibit Batch / Validation Batches at parent and site shift location. Review of trial batch protocol, Process Validation protocol and report, Hold time study protocol and report.