Biotechnology professional with over 28 years of experience in Quality Management Systems (QMS) and manufacturing within the global biotech industry. Extensive expertise in technology and process development, scale-up, and formulation of recombinant, conventional, conjugate, and subunit vaccines—both single and combination.
Proven track record in establishing and implementing QMS frameworks, leading validation activities, and driving comprehensive risk management strategies for both existing operations and new commercial facilities.
Experienced analytical scientist with over 16 years in the analysis and quality control of biotechnology products, with a strong focus on human and poultry vaccines in the global biotech and vaccine industry. Specialized in analytical method development, validation, and implementation within robust Quality Management Systems (QMS). Well-versed in animal handling, preclinical experimentation, and study execution, with hands-on experience supporting product characterization and regulatory compliance.
Accomplished biotechnology and pharmaceutical industry professional with over 24 years of experience spanning Manufacturing and Quality Assurance (QA). Demonstrated expertise in CAPA systems, GMP compliance, regulatory audits, and quality systems management. Recognized Subject Matter Expert (SME) in facility design and setup, equipment and process validations, risk management, and audit readiness for global regulatory bodies including USFDA, EMA, and TGA.
Certified Lead Auditor for ISO 9001:2015 and a qualified Associate Trainer, accredited by the International Board of Certified Trainers (Netherlands). Designated ISPE Ambassador with a strong track record of knowledge sharing and industry representation. Adept at building QMS frameworks, managing cross-functional teams, and supporting the launch and scale-up of commercial vaccine and biologics manufacturing facilities.
Dedicated and experienced biotechnology professional with over 20 years of hands-on expertise in downstream processing of vaccines, including Hepatitis B, Haemophilus influenza type b (Hib), and Pneumococcal vaccines.
Skilled in operating and maintaining equipment for purification processes such as filtration, chromatography, and centrifugation under GMP conditions.
Biotech professional with over 14 years of experience in Quality Management Systems (QMS) and manufacturing within the global vaccine and biotechnology industry. Specialized in fermentation processes involving bacterial, viral, and yeast-based platforms for human vaccines. Proven ability to support end-to-end development and manufacturing with a focus on quality, efficiency, and regulatory compliance.
Dr. Sonum Sharma is a dedicated Research Scientist with a Ph.D. from Shoolini University, Himachal Pradesh, and over 10 years of experience in academic research, including more than 5 years of postdoctoral research in the United States. She has held key research positions at Baylor College of Medicine, Houston, Texas, serving as both a Postdoctoral Fellow and Research Scientist. Dr. Sharma also brings 2 years of experience in the Intellectual Property (IP) industry, having worked as an IP Scientist with Corporate IP Consultants.
Her technical expertise spans molecular biology, cloning, plasmid biology, next-generation sequencing (NGS), and tissue engineering. With a strong foundation in both laboratory science and intellectual property, she brings a unique blend of research depth and innovation-driven insight to interdisciplinary scientific environments.
Seasoned Scientist with over 9 Years of Cross-disciplinary research experience covering Regulatory Audits and Compliances, with good experience of Quality Management System on vaccines/Pharmaceuticals/Biologics Vaccine industry.
Expertise in Quality Control Testing of Bacterial and Viral vaccines. Specialized in through and through testing of Bacterial, Viral, and Yeast based vaccines. In process as well final finished products.
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