Prabhat Shrivastava (M.Pharm., PhD)

• Company Overview: Piramal Pharma Ltd, Ahmedabad (Gujarat, India).
• Leading the team of scientists (12+) responsible for product and analytical development (Generics and NCE), optimization, process scaling-up, packaging, and CMC.
• Identifying new product development opportunity for continuity and growth of business with clients.
• Developing technical expertise in pediatric product development as a patient-centric approach.
• Demonstrated ability to manage complex project portfolio with scientific acumen.
• Supporting the team in technical challenges, the decision-making process, good documentation practices, and getting it right the first time (RFT).
• Collaborating with internal and external partners, i.e., analytical, manufacturing, biopharmaceutics, IPR, CMC, SCM, vendor, and project management team for on-time submission of product.
• Responsible for c-GMP lab for manufacturing clinical batches and maintaining quality and HSE compliance.
• Participate in equipment performance, lab automation, and new Capex proposal for capacity and capability enhancement.
• Supporting as a site leadership team member for continuous improvement plan in development, quality compliance, safety, and environment.
• Presenting critical milestone, considering the timeline, resources, technical constraints, and regulatory/quality requirements for committed deliverables to the governance committee.
• Initiate, monitor, and analyze financial targets, plan budget, and forecast, and allocate resources to meet customer expectations.
• Project scope evaluation for manufacturing feasibility, analytical requirement, scalability, and quality requirement.
• Promoting quality, speak up culture, and compliance across the group.
• Participation in the site initiative, i.e., talent recruitment, audit and compliance, patient centricity, operational excellence, and ESG activity.
• Effectively managing client communication, technical discussion, and expectations of project deliverables.
• Motivating and monitoring performance through setting goals and objectives, and timely reviewing the progress as a continuous improvement plan of the team.

• Company Overview: Torrent Pharmaceuticals, Ahmedabad (Gujarat, India)
• Led a team of scientists (10+) accountable for QbD-based product and process development, technology transfer, and CMC filing of solid oral, solution, complex generics, suspension, 505 (B2), and oncology products (US, EU, and IN territory) of internal and external R&D.
• Technically engaged in development strategy designing concerning polymorph, drug release modulation, patent landscape (Para-III & IV), poorly soluble active, stabilization, optimization, process performance, troubleshooting, bioequivalence, CMC, and market entry.
• Contributed to successful scaling up of manufacturing technology, troubleshooting, regulatory responses, and striving for continuous improvement of products and processes.
• Critical milestone mapping and timely achievement of key milestones.
• Participated in strategic planning, quality CMC documentation practice, decision/risk analysis, issue escalation and resolution, and effective communication while interacting with team members.
• Effectively managed the interface between team and other stakeholders (ADL, Regulatory, manufacturing site, supply chain, and marketing) to achieve expectations and requirements for project deliverables.
• Managed and monitored team performance through innovative thought processes, scientific knowledge sharing, and timely feedback, ensuring increased team productivity and quality.
• Proficient communication and project management skills, presentation, and convincing abilities to senior management. Leadership skills and strategic approach.

Accomplishments

• Regulatory submission 3 product (20-21), BE study cleared for three difficult-to-develop formulations and submission stages in 21-22.
• Under development, 14 solid oral products (Non-oncology-5, complex generic (CGT)-2, Oncology-5, Solution-1, suspension-1).
• Local FDA audit faced and received approval for oncology pilot batch GMP manufacturing lab.
• Elevated to the next management level based on performance.

• Company Overview: Torrent Pharmaceuticals, Ahmedabad (Gujarat, India)
• Led the team of scientists responsible for QbD-based research and development of complex solid oral generic and oncology products.
• Concept development, reverse engineering, pre-formulation, formulation design, stabilization, analytical development, process development, and technology transfer, and CMC to approval.
• Handled the projects of poorly soluble and unstable actives using novel polymorphic form selection, stabilization, HME, extrusion, and spheronization, solid dispersion, and spray drying approach.
• Basic understanding of IVIVC model (Phoenix and GastroPlus) and discriminatory and bio-relevant dissolution media.
• Clinical study design selection based on the molecule's clinical assessment.
• Dealt with complexities around the development cycle, including IP, regulatory, pharmacokinetics, and manufacturing, followed by differentiation of the product to address unmet clinical needs.
• Prepared and reviewed the specification, product development report, scientific justification, BMR, and other regulatory documents.
• Quality compliance support for investigation and risk analysis/evaluation of OOS & OOT, audit, and technical regulatory queries.
• Exposure and implementation of the continuous manufacturing process (Consigma), Plug and Play granulation suite, and real-time release process analytical tools (PAT-NIR, Parsum, Eyecon, and Torque measurement system).

Accomplishments

• A key player in the development, execution, and regulatory submission of 6 solid oral and 1 FTF product.
• Contributed towards 6 oncology and 2 non-oncology products at the Pilot BE stage.
• Completed Pilot BE, scale-up batches of complex generic gel matrix-based ER tablet (urinary disorder) and pelletization-based (PPI) product.
• Develop and establish a high-containment GMP lab for oncology products.
• Key person in solid oral oncology product commercial manufacturing, Greenfield project.
• Consistently received outstanding performance in the past 3 years.

• Company Overview: Worked for Global Healthcare Company.
• Technical writing and review of QbD-based CMC module 3, i.e., product development and analytical development data review, submission batches, and stability data evaluation, and regulatory submission.
• Product-specific risk assessment and global CMC document harmonization.
• Responding to technical queries related to product development to the competent authority.
• First point of contact for client interaction regarding project objectives, scope, and deliverables, along with high-level timelines.

• Company Overview: Aurangabad, (MH)
• Technically engaged in the development of technology-based products, i.e., Matrix-controlled release, Pulsatile drug delivery, multiparticulate drug delivery, and Osmotic-controlled release oral system.
• Developed products as per QbD, i.e. QTPP, risk assessment, design of experiment (DoE), formula (CMA), and process optimization (CPP) define design space with control strategy.
• Developed the product based on manufacturing processes, i.e., wet & dry granulation, Wurster process, tablet in tablet, compression, coating, and capsule filling process.
• Prepared product specification, product development report as per QbD, MFC, and compilation of raw data.
• Data analysis and interpretation of analytical results.
• Technology transferred to manufacturing plants and supported in regulatory dossier filing.

Accomplishments

• Successfully filed 4 products in Europe and 2 in the US.
• Involved in the development and transfer of 6 products.

• Company Overview: Department of Pharmaceutical Engineering, Varanasi (UP).
• Developed and characterized polymeric drug delivery system with biodegradable polymer.

• Pharmaceutical product development and in-vitro dissolution of IR tablets & stability studies