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Video meeting . 15 mins
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Video meeting . 15 mins
800
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Priority DM . 2 days reply
FREE
Video meeting . 30 mins
1,050

About me

# Passionate Biopharma Professional and Leader with competency in Early (Pre-clinical) and Late-stage (Clinical) Biologics (antibodies and biosimilars) and Vaccine drug product development, Novel and advanced drug delivery based Product development CMC, project management and seamless execution. # Strategic thinking executive, experienced in supporting corporate initiatives and Demonstrated ability to drive efficiency and profitability based on skills, team management and decision making. # Consistency and track record of >20 years in the Development and Commercialization of Protein conjugates, Live and attenuated viruses, AAV, Plasmids and RNA based therapeutic modalities Accelerated & cost-effective development of advanced and innovative technologies for biologics products based on #QbD and #Design of Experiments (DoEs) principles for defining Control strategies for large scale #cGMP manufacturing . Proven scientific acumen, hands-on leadership, and stellar track record of success in product development across various pharmaceutical dosage forms and technologies especially #Sterile injectables, Transdermal (Topical) and Oral dosage form for biologics DP, from proof of concept to product validation and Commercial Manufacturing Fostered synergistic alliances and partnerships with executive management, vendors, and cross-functional teams such as QA, RA, operations, etc. Specialties-:* - Protein conjugates based therapeutic modalities i.e. Multivalent Pneumococcal conjugate, Hib and Men A conjugate based vaccine(s) - High Throughput Screening (HTS) Technologies for Biologics drug product development - Novel & Advanced Delivery based Platform Technologies for novel Biologics/NBEs, Proteins, DNA & mRNA. - Multivalent or Combination based Complex Biologics Drug Product Development - Stabilization of challenging and stimuli-sensitive biomolecule(s) for Product Development - Lyophilization and Spray Drying based drug product for thermo-sensitive biomolecules - Sterile (Injectables) and Oral drug product development and manufacturing, - Particle design and Engineering, - Pre-formulation and DP Characterization of biologics products - Nucleic acid-based therapeutics i.e. Gene & mRNA based DP development CMC