Orbit Pharma
Delivering Excellence

Technology Transfer (Regulated Market)

Minimum qualifications

  • Bachelor’s and master’s degrees in the pharmacy
  • 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.