1. Process development studies by DOE(Lab Scale and pilot Scale)
Identifying the critical process parameters and analyzing (By DOE )
Process optimization studies by DOE
Identifying the critical process parameters and analyzing by DOE (Finally getting robust process)
Defining the Design space by DOE
Selection of equipment for each product and defining smooth process
Execution of pilot batches, confirmatory batch and Pre validation batches (Pilot BE Studies)
Conducting Risk assessment and Evaluation (SHE & ICH)
Scale-up & scale down by applying advance statistical tools (Correlation Mathematically)
Execution of pivotal batches, Validation batches (Submission or Stability batches or BE Studies)
Conducting Risk assessment
Risk evaluation and risk control & review activities (FMEA, Control Strategy & using Risk
Management Tools)
Preparation for commercial launching (Pre-validation, Validation studies )
Establishing the specification limits for commercial products (Statistically)
Product launching at commercial scale.
Using PAT tools (All the Stages)
Regular checks For product Continuous Monitoring and Improvements(ICH Q10)
Technology transfer of products & process to different locations (CMO)
Conducting the optimization and validation studies at CMO Site.
Defining the design space (CMO)
Establishing the specification limits for commercial products at CMO Locations (Statistically)
Process development from lab scale to pilot plant and production locations (Scale Up)
Introduce the new technology’s and tools into development and commercialized products
Responding to Pre filling & post filling queries and deficiencies
Handling the production trouble shooting problems
Expertise work in Extensive formulation: Granulation, Extruder & Spheronizer and Hot melt
extruder and tablets, capsules, pellets, semi solids, powders
Supporting to qualification process (IQ,OQ,PQ in plant, R&D Equipments)

2. Preparation and review of all supporting documents (DOE Design, Process development
protocols, process optimization documents, confirmatory batch documents, pilot and pivotal batch
documents, hold time study documents, validation documents, launch preparation documents, and
QbD documents)
Preparation & review of CMA, CQA, Control strategy, FMEA documents (Qby D)
Preparation & review of CPP, SDSI, and risk assessment, EHS safety documents(Process)
Preparation & review of Product Development Report, optimization reports, pre validation
reports, validation reports.
Preparation & review of Protocols like Hold time, Validation, sampling
Preparation & review of SOP’s, BMR, BPR, MFR,S documents & Hold Time study
Providing the support to teams in new technologies End point Determination (Granulation- using
Torque, NIR, FT4, power factors technology’s )
Supporting & follow-ups to RA, IPR teem making eCTD documentation and filling on time
Artwork development coordinate with package development
Interpretation of dissolution data vs c (IVIVC)
Expert in advance analytical techniques like Practical size, Wettability, BET, SEM, and
Morphology, FT4 powder flow properties, DVS, Surface charges and NIR interpretation
Evaluating new and interesting technologies applicable for Formulations
Supporting and encouraging to the team and functional teams (Project Management)
Analytical method development support and regular analysis
Preparation for Quality Systems with CAPA Processing
Actively working Project Management activities