Technology Transfer Executive, Mysuru

Role & responsibilities:

• Formulation Operations based optimization of process like Granulation (Wet granulation/ Dry granulation), Compression, Coating and Capsule and FBP (Bottom & Top Spray).
• Have profound exposure in development and manufacturing of solid dosage form like tablets, capsules.
• Preparation of TT documents like MFC, BOM, QTPP and PDR as per ICH guidelines.
• Monitoring & execution of the Pre-Exhibit batches and validation batches.
• Proposing the batch size i.e. of the Demo/Placebo, Exhibit & Commercial batches in view of equipment Suitability / capacity at the manufacturing site.
• Preparation of Intended document i.e. Batch processing record and Batch manufacturing record.
• Actively taking part in the investigation of problems arise in manufacturing of solid oral dosage forms.
• Responsible for coordinating with cross-functional teams as per the requirement and extend help in delivery of projects on time.
• Planning and Monitoring of Submission/ Validation/ Evaluation/ Process Qualification batches for Technology Transfer of New Products & Existing Products.
• Investigating product failures occurs during submission batches, validation batches, and commercial batches.
• Preparation and Review of Scale up formula card, Manufacturing formula card, Batch Manufacturing Records, scale up reports, Standard Operating Procedures, Batch Completion Certificate &Sampling plan for scale up batches.
• Handling trouble shooting activities in Scale up and Exhibit batches.
• Evaluation of critical process parameters during Optimization, Exhibit, and Validation batches.

Preferred candidate profile:
†To execute and monitor the Scale-up batch and Exhibit batch.
†To Prepare Miscellaneous study protocol and report.
• To prepare Batch size Scale-up BMR and Scale-up Report.
• To ensure the availability of the equipment’s required for the execution of Scale-up batches and exhibit batches while preparing the batch documents.
• Well-versed with OSD Manufacturing and Packing activities
• Good communication and interpersonal skills
• Good knowledge of European agency guidelines
• Sound knowledge of ALCOA+ concept.