Vaxbiosolutions
VaxBioSolutions is a global consultancy specialising in technical CMC, clinical trials manufacturing, and market authorization for vaccines and biological products. By partnering with researchers and organisations worldwide, the company helps streamline the journey from early innovation to commercialisation. Its work plays a key role in advancing public health and accelerating the development of life‑saving vaccines and biologicals.
Key achievements
- Led end‑to‑end development of 50+ vaccine candidates through clinical trial readiness, with 11 successfully achieving market authorization across global regulatory agencies.
- Directed CMC and manufacturing strategy for high‑profile programs, including COVID‑19 vaccines, malaria vaccines, and HPV therapeutic candidates, ensuring technical excellence and regulatory alignment.
- Managed and mentored cross‑functional scientific and operational teams spanning India, the UK, Europe, and the US, fostering collaboration and delivering complex programs on accelerated timelines.
- Delivered multiple global client programs in vaccines and biologicals, consistently meeting technical, regulatory, and commercial milestones.
Team expertise
QC and QA expert
- Seasoned QA/QC professional with over 22 years in the biopharma industry, specializing in biosimilars, cell & gene therapy, and vaccines.
- Experienced with global regulatory inspections (US-FDA, MHRA, EMA, etc.) and a trained internal/external auditor.
- Strong in failure investigations, CAPA implementation, and proficient in eQMS tools like Trackwise, Simploud, and LIMS.
- Expert in developing compliant Quality Management Systems aligned with ISO, USFDA, ICH, and EU standards.
Team expertise
Bioprocess Scale up and Technology transfer expert
- Over two decades of leadership in the biotechnology sector, specializing in mAbs, Vaccines (Human, recombinant, glycoconjugate, animal, poultry), Infectious Diseases, next generation platforms- AAV, Lentiviral and biotherapeutics
- Extensive experience across the entire product lifecycle from discovery to market launch, with a focus on accelerating product readiness during pandemics.
- Led multiple technology transfers, clinical and commercial operations, CMC submissions and CDMO site operations
- Oversaw full-spectrum CMC activities—from development through manufacturing (USP/DSP/Formulation) in alignment with US FDA,EU and WHO regulatory requirements
- End-to-end site operations, establishing infrastructure and capabilities (Greenfield and Brownfield projects for high-containment (BSL-2+) R&D, process development, cGMP manufacturing
- Pioneered the adoption of new technologies to improve operational excellence across biologics, CGT, mAbs, and vaccines.
Team expertise
Pre-clinical research expert
- Passionate researcher and science manager with over 25 years of R&D experience focused on infectious and non-communicable diseases.
- Experienced in translating innovative research from bench to bedside, demonstrating strong problem-solving and leadership skills.
- Led cross-functional teams to execute strategic research initiatives and groundbreaking projects.
- Secured over 10 collaborative projects funded by the European Commission, national governments, and private investors.
- Acted as the primary liaison between research consortia, stakeholders, customers, and funding agencies to fostering collaboration and managing complex research partnerships.
- Inventor of 3 international patents and author of multiple scientific publications.
Team expertise
Finance and Administration lead
- Over 15 years of experience in accounting, finance, and administration roles.
- Skilled in financial reporting, budgeting, and process optimization.
- Adept at managing administrative operations and ensuring compliance.
- Committed to driving efficiency and supporting organizational growth.
Team expertise
Project manager
- Over 20 years of experience in Labeling, including 11 years in global drug labeling.
- As a lead consultant worked with Sanofi and Johnson & Johnson, managing regulatory labeling and artwork reviews.
- Skilled in handling complex Health Authority queries and ensuring compliance with international regulatory standards.
- Expertise includes medical device documentation, CE marking, 510(k) submissions, and pharmacovigilance support.
- Proficient in regulatory systems like Veeva Vault, CONNECT, and COCOON, delivering efficient, compliant solutions globally.