2-3 years of relevant experience in scale-up and technology transfer of products for regulated markets.
Roles and Responsibilities
Identify the contract Manufacturing Organisation.
Negotiate the business terms and timelines.
Scale-up/ Optimisation /Validation batches execution and monitoring of solid, semi-solid liquid dosage forms(Sterile and Non Sterile).
Evaluation of gap analysis, risk assessment before start of technology transfer activities for site readiness.
Batch size calculations, Selection of equipments for Scale-up/ Optimisation /Validation batches.
Documentation - preparation of documents like MFR, MPR, PVP, PVR, Sampling protocol, cleaning validation, Stability protocol, Hold time study protocol, Product specifications etc. as per regulatory
requirements.
Troubleshooting and optimization of process parameters to minimize risk during tech transfer.
Understanding of processes, functions, technologies, materials and equipment(s).
Coordinate with cross-functional teams like purchase, QC/ADL, Production/F&D, QA and RA for smooth technology transfer and filing of the products.
Preparation of response to regulatory agency queries relevant to technology transfer.
Knowledge of cGMP, GDP, ICH, EMA and SUPAC guidelines.
Scale-up lab management.
Maintenance of inventory for Scale-up/ Optimisation /Validation batches.
Skills / Abilities
Good oral and written communication skills.
Sound knowledge of troubleshooting, and understanding of processes, functions, technologies, materials, and equipment. Proven hands-on experience.
