Ayshwarya Sivakumar Email & Phone Number

Iceland

Reykjavík, Capital Region, Iceland

-Responsible for performing data compilation and trending for continuous monitoring and process improvement of Drug Product Manufacturing-Identifying process related gaps for operations improvement and lean manufacturing-Providing support for Visual Inspection data trending and compilation- Support for audit activities by co-ordination with cross functional team within the scope of DP MSAT-Mindfully carry out DP MSAT team activities in a safe and cGMP/EHS/Regulatory compliant manner. -Responsible for generation of quality documents during batch manufacturing(clinical/PPQ/commercial) i.e., process related deviations/change control/CAPA and OOS/OOT/OOR Phase II investigations etc.-Subject Matter Expert (SME) author, reviewer and approver of Deviations, CAPAs and change controls relating to DPM processes and written procedures, SOPs etc.

Kingston, Ontario, Canada

Bengaluru, Karnataka, India

-Sourcing and Procurement advisories-Bridging the supply chain gaps and provide value added solutions

Chennai Area, India

-Provide procurement intelligence to the stakeholder in various aspects of pharmaceutical packaging and support them in best supplier engagement-Conduct primary and secondary research to offer best sourcing practices across the industry-Understand the market dynamics and provide the best fit sourcing model as per the requirement-Present the data and support the additional queries put forth by the stakeholder-Author articles and packaging digests which capture recent industry events and latest innovations

Bengaluru Area, India

-Define scope of the market and perform secondary research to further understand the market-Gain quantitative and qualitative data to provide insights on the size of the market and its various segmentation-List out the factors that propel the market and those that impede its growth including the latest trends in the defined market-Provide market and competitive insights for real time decision making and long term gains

Bangalore

-Quantitative analysis of contaminants like Leach Protein A and Host Cell Proteins in purified MAbs by ELISA.-Comparison of charge variants using Iso-electric focusing Ion-exchange HPLC and size variants using Size exclusion HPLC and SDS-PAGE.-Determine hydrophobicity of proteins using HIC-HPLC.-Determine protein concentration by UV based methods.-Analyze and document results for downstream purification of therapeutic proteins.-Present data and provide inputs for further process development in MAb purification.-Active participation in team building activities and organizing of the same.

Chennai Area, India

-Analysis of quality of tablets and capsules by RP-HPLC.-Determine water content in capsules using KF titrator.-Determine bacterial and fungal resistivity in capsules.-Record analysis process and troubleshoot HPLC issues.-Maintaining clean and safe environment.

Master Of Business Administration (M.B.A.), Business Administration And Management, General

Activities and Societies: -Organizing member of 'THE ULTIMATE MANAGER', an event in PRAGYAN, the techno-management festival.

Bachelor’S Degree, Biotechnology, Cgpa 8.2

Activities and Societies: -Anchoring and member of Organizing commitee in 'Technical symposium for Food Technology' hosted by college.

High School, Bio-Maths

Participated in inter-school competitions across various zones. Involved in all cultural and provisional programs.