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.
