To execute and review data of the lab scale batch formula optimization, process optimization and help in trouble shooting in process development.
To ensure smooth technology demo to tech transfer team based on QbD and DoE approach.
Expert in handling all kind of formulation equipment at lab scale and at manufacturing scale and able to establish scale up calculation.
Process development by QbD approaches using structured DOE trials to develop robust process and its control that supports manufacturing of oral solid dosage forms.
Verify and receive projects from Development team for optimization and scale up at R&D and manufacturing locations.
Identification of Critical Process Parameters(CPP’s), Scale Dependent and Scale Independent parameters.
Conducting process FMEA discussion to identify the critical process parameter and risk mitigation.
Execution of Exhibit Batches at pilot scale and monitoring stability of the product.
Preparation, review and recommendations for Process Optimization report and PDR.
Application of scientific and engineering principles to develop process understanding and scale up from laboratory to commercial scale. (knowledge on PAT Tools like NIR, FT4, Malvern, Parsum Probe, DVS, ASAP).
Independently handling site transfer activities, Process validation batches.
Higher education (pharmacy, chemistry).
Minimum 5 years experience in formula optimization, process optimization and help in trouble shooting in process development.
Experience in handling all kind of formulation equipment at lab scale and at manufacturing scale.
Experience in tech transfer based on QbD and DoE approach.
Knowledge on PAT Tools like NIR, FT4, Malvern, Parsum Probe, DVS, ASAP.
Knowledge of technology and pharmaceutical formulation for solid dosage forms.
Experience in working with English documentation (translation, communication, written / verbal documentation).
PC operation (Word, Excel, Internet, email communication).
Ability to analyze and attention to detail.
Relative skills for finding solutions of common interest in departments and working groups.