Prafulla Mahajan
Senior Principal Scientist Manager R & d @Lonza
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WORK HISTORY
Senior Principal Scientist Manager R & d @Lonza
Slough, GB
Technical Expert leading a team of experienced scientists in process characterization studies, enabling customer projects for successful BLA (Biologics License Application) filing. Responsible for people and performance management, including mentoring, technical reviews, and driving team performance to achieve organizational goals. Additionally, spearheading strategic projects to enhance departmental functions and operational efficiency.
EDUCATION
Mumbai University Institute of Chemical Technology
Master of Technology, Bioprocess Technology
K.M.Kundnani College of Pharmacy, University of Mumbai
B.Pharm, Pharmaceutical Sciences
Institute of Chemical Technology
Doctor of Philosophy, Bioprocess Technology
SKILLS
ABOUT PRAFULLA MAHAJAN
Ph.D. in Bio-process technology with 20 years of research experience and over 13 years of Industrial experience developing Biosimilar and Novel Biologics using Mammalian Cell Culture; has published 5 research articles and filed 7 process patents Strong technical background in bio-process development specifically process development of mammalian cell culture (CHO, SP2/0) and microbial fermentation Clone evaluation and selection, media and feed screening, optimization of process parameters to improve productivity and match biosimilarity Process development and optimization using shake flask, ambr15, & bench top bioreactors (5 & 10 L) using QbD (DOE, CQA) toolsTechnology transfer and establishment of process consistency and quality across the scales (3L & 200L)Scale-up and scale-down of cell culture processLarge scale (50 & 200 L) bioreactor characterization, mass transfer and mixing time studies Experience in cGMP operations for generation of material for clinical TrialsWell versed with application of DOE principles and multivariate data analysis by effective utilization of various software like JMP®, MODDE® and Design-Expert® Risk assessment (FMEA) and mitigation for cell culture process development and process characterization studies.
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