Sirisha Ganapuram
Manager, Analytical R&D
- Role
- Manager Analytical R & d at AbbVie
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Sirisha Ganapuram
As a Strategic Leader, Principal Scientist and a Registered Pharmacist, with over 15 years of experience spanning Pharmaceuticals Research, Development, Implementation and life cycle management, my mission is to innovate, problem-solve, and achieve results that make a difference in the lives of patients while also contributing towards Scientific advancement.As an analytical R&D SME and technical leader with strong background in Method Development, Validation, Characterization, Bioanalysis, Tech Transfer, and Regulatory filings for small molecules and proteins. I use QbD principles within LC-HRMS, LC-MS/MS, and other advanced analytical techniques to develop methods that help in identification and quantitation of trace level mutagenic impurities, elemental impurities, and extractables-leachables. I collaborate with CROs/CMOs/CDMOs to ensure product quality, regulatory compliance, and speed to market. Currently, I am working on developing and implementing analytical strategies for Nitrosamine impurities in solid oral and sterile injectable drug products, supporting NDA/PAS applications, and resolving FDA deficiencies.
Experience
Manager Analytical R & d
Apr 2024 — Present · North Chicago, IL, US
Education
Campbell University
Master of Science in Pharmaceutical Sciences, Pharmaceutics (Industrial Pharmacy)
2009 — 2011
Osmania University
Bachelor of Pharmacy, Pharmaceutical sciences
2005 — 2009
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