Ajit Dansena
R & d Manager @Transasia Bio-Medicals Ltd.
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WORK HISTORY
R & d Manager @Transasia Bio-Medicals Ltd.
Led development and validation of molecular diagnostic assays (RT-PCR) for infectious diseases including HIV, HBV, HCV, TB, Dengue, Chikungunya, and NTM – from feasibility to commercialization.Directed the design and optimization of nucleic acid extraction protocols, PCR assay formulation, and lyophilized master mixes tailored for use on automated platforms.Managed instrument validation of proprietary Real-Time PCR systems (e.g, Erba MX8), including:Performance qualification (PQ), installation qualification (IQ), and operational qualification (OQ).System integration with consumables and reagents.Troubleshooting hardware-software issues to ensure optimal assay compatibility.Oversaw clinical trials in collaboration with NABL-accredited labs and hospitals:Drafted protocols and Case Report Forms (CRFs).Coordinated ethical approvals, site training, and data collection.Analyzed trial data for regulatory reporting and product performance claims.Ensured regulatory compliance with:CDSCO (India): Managed Form MD-14/15 applications, performance evaluation studies, and IFU validation.WHO Prequalification (PQ): Led dossier preparation, external site validations, and follow-up queries.CE-IVD (IVDR 2017/746): Authored and maintained Technical Documentation, Risk Management Files (ISO 14971), and Performance Evaluation Reports.Spearheaded preparation of Validation Master Plans (VMPs), verification protocols (IQ/OQ/PQ), and SOPs for new product introductions.Actively participated in ISO 13485:2016 QMS audits, internal reviews, and external regulatory inspections.Mentored junior scientists and coordinated cross-functional teams to meet R&D milestones and strategic goals.
EDUCATION
Central University of Gujarat
Master’s Degree, LIFE SCIENCES
DY Patil University
Master of Business Administration - MBA, Project Management
Garden City University
Bachelor’s Degree, Biotechnology ,genetics , Biochemistry
Sarswati Shishu Mandir Raigarh
High School, Biology, General
ABOUT AJIT DANSENA
As I have done my bachelors in Biotechnology and completed my masters in Life Sciences, I…
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