K.V.S. Rao

R&D Manager

Dr Reddy Ltd

January 2006 to March 2013

Responsible for overall leadership to the formulation team in terms of direction and from a mentor, coach and development perspective.
Providing a robust training program including technical, to be delivered to the teams including new starters.
Encourage and support the team to participate in the project management process
Playing an active role in the matrix management system
Budgeting and Strategy Designing for new products
Clinical trials, BA/BE studies Feasibility, Protocols review, budgeting
Responsible for implementation, monitoring of innovative process & Project proposals and timelines
Logistic sourcing & proper utilization of resources
Driving ideation and innovation within assigned Category
Overall resolution of all technical issues associated with product development & Clinical & BA/BE studies
Responsible for the effective management of project budget & cross functional project management team issues
Monitoring & tracking of project pipeline & resolution of all complaints issues
Responsible for implementation, monitoring and reporting of performance metrics and take corrective action
Preparation & review of CMA, CQA, Control strategy, FMEA documents (Qby D)
Preparation & review of CPP, SDSI, and risk assessment, EHS safety documents
Preparation & review of Product Development Report.(Q by D in PDR)
Preparation & review of Protocols like Hold time, Validation, sampling
Participation and Execution of pilot & pivotal batches
Process development from lab scale to pilot plant and production locations(Scale Up)
Technology transfer of products & process to different locations
Introduce the new technology?s and tools into development and commercialized products
Providing the support to teams in new technologies End point Determination (Granulation- using Torque, NIR, FT4, power factors technology?s )
Scale-up scale down by applying advance statistical tools
Responding to Pre filling & post filling queries and deficiencies
Handling the production trouble shooting problems
Preparation & review of SOP?s, BMR, BPR, MFR,S documents
Expertise work in Extensive formulation: Granulation, spray drying, Extruder & Spheronizer and Hot melt extruder and tablets, capsules, pellets, semi solids, powders
Expertise work in process cycle setup and cycle optimization for Lyophilizer
Development of injectable products (Lyophilized, liquids, Nano-suspensions)
Scale up, validation and technology transfer of all the products
Supporting to qualification process (IQ,OQ,PQ in plant, R&D Equipments)
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
Analytical method development support and regular analysis
Preparation for Post Market Surveillance activities
Preparation for Quality Systems with CAPA Processing

Career Goals

Industries of interest

Areas of interest

Availability to travel and work outside the city

No

Interests and hobbies