Vishwa Patel
Quality Control Analyst at Biogen
- Role
- Quality Control Analyst at Biogen
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Vishwa Patel
Quality Control Analyst with over 4 years in biopharma and vaccine development…
Experience
Quality Control Analyst
Mar 2025 — Present
Performed qPCR and dPCR assays to quantify nucleic acids, ensuring monoclonal antibody batch quality byfollowing GMP and FDA regulatory standards, maintaining consistent product integrity throughoutmanufacturing processes.•Executed HPLC and SEC chromatography analyses to monitor biologic sample purity, aggregation, andstability, supporting batch release and quality assurance in compliance with industry regulations.•Managed ultrafiltration/diafiltration processes and bioreactor sampling to guarantee consistent downstreamprocessing, preserving product quality during multiple manufacturing runs across different production scales.•Investigated assay deviations by troubleshooting protocols and analyzing data thoroughly, maintaining assayaccuracy and ensuring full regulatory compliance in laboratory testing environments.•Updated, maintained, and implemented SOPs and documentation to support FDA audits, internal qualitysystem reviews, and continuous improvement initiatives within the QC department.
Education
Nirma University
Bachelor's degree, Pharmacy
2018
Northeastern University
Masters of science in Biotechnology, Biotechnology
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.