Shalaka Purohit

About Shalaka Purohit

Bio-process Development and Product Commercialization professional with 23 years’ experience in end to end Development, Operations and Relationship Management. A strategic thinker who combines technical and business insights with program management support to deliver key milestones under tight time lines and budgets.• Experience spans bio-pharma, industrial biotechnology and biofuels platforms• Outstanding leadership, organization, communication and relationship management skills to successfully lead teams with in-house, third-party, remote and blended resource models SKILLSBiopharmaceutical CMC, Process Development, Optimization, Technology Transfer, Scale-Up strategyTechnical Operations and Regulatory DocumentationProject and Program Management, Relationship Management

Experience

1. Founder, Principal, Consultant

   Suveda Solutions Inc

   Jul 2011 — Present

   Consult with virtual, small and mid-size biotechnology companies. Support executive and scientific teams in formulating strategy and road maps for product development, conducting gap analysis, risk assessment, resource planning and compiling Grant or VC Funding proposals. Biopharmaceuticals-Focus area- CMC- product classes- monoclonal antibodies, therapeutic proteins, peptides and cell and gene therapies•Assist clients with researching and selecting CRO, CMO partners to complement in-house resources, and then managing and guiding activities to meet program targets- subject matter expertise in Formulation, Drug Product Development, ICH Stability Studies, Expiry Dating, Clinical Label Pack, CMC-Clinical-operations and Demand Supply Modeling•Set strong, phase appropriate QbD and compliance foundation•Author and manage regulatory document preparation- pIND, IND, IMPD submissions, support BLA enabling process characterization, remedying clinical hold situations•Complement Clinical operations with in-use compatibility studies, procuring ancillaries and implementing stage-appropriate supply chain management strategies for U.S, and rest of the world.Industrial Biotechnology- Focus area-product development and commercialization- industrial enzymes, nutraceuticals, supplements, biofuels and value-added chemicals•Seamlessly integrate in-house work streams, with those at various CROs, CMOs, for process and product development, operational optimization and excellence to support regulatory submissions and achievement of technical and business milestonesTechnology Incubation, Start-Up, Venture-Played a key role in the start-up and management of a biotechnology incubator in Pune, India, currently serving over 35 start-up ventures, in the clean tech, medical device, and biopharma space

Education

• University of Mumbai

  Masters in Science and Technology, Bioprocess Technology

  1995 — 1997

• UC San Diego

  Certificate, Biotech Project Management

  2007 — 2008

• Bharati Vidyapeeth

  Bachelors in Pharmacy, Pharmacy

  1991 — 1995

• University of Pune- Ranade Institute

  Advanced Diploma in German, German

  1993 — 1995

Skills

• Biopharmaceuticals
• Elisa
• Process Development
• Biotechnology
• Troubleshooting
• Microbiology
• Project and Program Management
• Sop
• Relationship Management
• Formulation
• Enzymes
• Life Sciences
• Biochemistry
• Biofuels
• Fermentation
• Manufacturing Scale-Up
• Purification
• Technical Presentations
• Molecular Biology
• Process Simulation
• Technical Documentation
• Pcr
• Process Efficiency
• Downstream Processing
• Technology Transfer