Rahul Mishra
Senior Analytical Scientist @AstraZeneca
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WORK HISTORY
Senior Analytical Scientist @AstraZeneca
Cambridge, GB
Represent Analytical Development on CMC project teams, driving analytical strategies aligned with global regulatory expectations for biologics.Lead analytical sub-teams across DS/DP development, characterization, QC, and stability, ensuring delivery of CMC packages.Author, review, and oversee CMC analytical documents including method development reports, validation protocols, comparability strategies, and regulatory responses.Engage with health authorities, contributing to submission packages and audit interactions.Manage global CDMO/CRO analytical activities, ensuring data integrity, compliance, and timely execution.Mentor and supervise junior scientists and PhD researchers; foster technical skill development and scientific innovation.Co-lead the Electrophoresis SME group, directing method development, technology evaluation, and remediation of legacy methods.
EDUCATION
St. Anselm's Sr. Sec. School
Biotechnology
University of Rajasthan
Bachelor of Engineering (BEng), Biotechnology
School of Biotechnology, RGPV, Bhopal
Master of Technology (M.Tech.), Biotechnology
Indian Institute of Technology, Kanpur
Doctor of Philosophy - PhD, Structural Biology
SKILLS
ABOUT RAHUL MISHRA
Analytical project leader with global biopharmaceutical experience in analytical strategy, CMC leadership, method development, validation, stability, and comparability across novel biologics and biosimilars. I specialize in integrating analytical sciences into cross-functional CMC programs, driving regulatory-aligned strategies, and ensuring high-quality data packages for global submissions.At AstraZeneca (Cambridge, UK), I represent Analytical Development on CMC project teams, lead analytical sub-teams across DS/DP, characterization, and QC, and contribute to IND/BLA/CTA submissions. I manage global CRO/CDMO analytical activities, ensure regulatory compliance, and engage with health authorities through submission and audit interactions. I also co-lead the Electrophoresis SME group, advancing platform method development and introducing new analytical technologies.Previously at Intas Biopharmaceuticals (India), I led analytical projects for multiple biosimilar programs, overseeing method development, qualification, stability study design, comparability assessments, and regulatory filings.My PhD from IIT Kanpur provides strong grounding in protein self-assembly, structural characterization, and biophysics, which underpins my analytical judgment and scientific problem-solving.I am passionate about mentoring scientists, driving innovation, and building robust analytical strategies to accelerate biotherapeutic development from early discovery to commercial readiness.
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