SHARAD PACHARANE

R&D : Formulation development

Experimental design:

• Design, plan, and conduct experiments to develop new drug formulations, delivery systems, and pharmaceutical products which is stable and bio-equivalent.
• Optimize existing products and processes to improve efficacy, safety, and stability.

Data Analysis and Interpretation:

• Analyze experimental data using statistical and computational tools.
• Interpret results to draw meaningful conclusions and guide subsequent research activities.
• Prepare technical reports, publications, and presentations to communicate findings.

Project Management:

• Manage research projects, including planning, scheduling, and resource allocation.
• Ensure projects are completed on time and within budget.
• Collaborate with project teams to align research activities with project goals and timelines.

MSAT (Manufacturing Science and Technology)

Process Transfer and Validation:

• Facilitate the transfer of new products and processes from R&D to manufacturing.
• Ensure processes are scalable, robust, and compliant with regulatory requirements.
• Experience with process validation, technology transfer, and process improvement.

Technical Support:

• Provide technical support for troubleshooting and resolving manufacturing issues.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA).
• Support deviation investigations and change control activities.

Continuous Improvement:

• Identify and implement process improvements to enhance efficiency, yield, and product quality.
• Utilize Statistical Process Control (SPC) and other process improvement methodologies.
• Collaborate with production teams to optimize manufacturing operations.

Documentation and Compliance:

• Review technical documentation, including SOPs, batch records, and technical reports.
• Ensure compliance with GMP, FDA, and other regulatory requirements.
• Support regulatory filings and inspections.

Cross-Functional Collaboration:

• Work closely with R&D, Quality Assurance, Regulatory Affairs, and Production teams.
• Participate in cross-functional project teams to support product development and commercialization.
• Provide technical training and mentorship to manufacturing personnel.

Technical Skills:

• Strong understanding of manufacturing processes
• Experience with process validation, technology transfer, and process improvement.
• Proficiency in statistical analysis and process optimization tools (e.g., DOE, SPC).

Soft Skills:

• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work independently and in a team environment.

Technical Expertise:

• Expertise in formulation development, drug delivery systems, and pharmaceutical analysis. In-depth knowledge of manufacturing processes and technologies.
• Attention to Detail: Ability to identify and address process deviations and non-conformities.

Project Management: Strong organizational skills and ability to manage multiple projects simultaneously.

Regulatory Knowledge: Familiarity with regulatory requirements and guidelines (e.g., GMP, FDA, EMA).

Innovation: Creative thinking and a proactive approach to identifying and solving research and process challenges.

• Presented research findings at conferences or other professional gatherings effectively conveying complex ideas in an understandable manner to audiences from various scientific backgrounds.
• Reviewed reports from subcontractors to document and achieve technical milestones and deliverables.
• Ensured accurate data collection and analysis, leading to high-quality research outcomes.
• Developed comprehensive project plans with clear objectives, milestones, and resource allocation strategies.
• Increased team efficiency through regular progress monitoring and implementing corrective actions when necessary.
• Successfully managed multiple concurrent projects while maintaining excellent organization skills and attention to detail throughout each stage of the process.

• Enhanced research efficiency by streamlining laboratory processes and implementing best practices.
• Increased project success rates through effective team management and timely communication with stakeholders.
• Collaborated closely with regulatory authorities throughout the product development process ensuring compliance adherence and expedited approval timelines.
• Supporting work for other products: Query response for US and Europe market,Market Extension.
• Provides technical leadership for manufacturing responsibilities included process and product investigations, continuous process improvement, lifecycle management, technology transfer, and process validation.
• Focused on developing QbD risk assessment methodology in collaboration with process development, technical services, and quality assurance.
• Collaborates on late stage/ commercial projects towards establishing risk-based control strategy for process validation, process transfer, and process changes.
• Assess formulation development reports. Prepare and execute studies planned to define processing ranges.
• Assists in alternate vendor development to validate vendor in defined processing windows.
• Leads the technical process evaluation for Technical Transfer projects. Review the existing processes/equipment used and prepare studies to revise the process to align with plant capabilities/equipment/processes and maintain all product attributes.
• Leads/ supports cross-functional activities related to development, deployment, and continuous improvement of QbD approach.
• Supports regulatory inspections and filings as an author and reviewer.
• Familiar with CMC-related activities, including formulation development, process development, and container/closure.
• Supports GLP/GMP manufacturing, including provision of process instructions, batch record review, and acting as a hands-on resource.

• Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
• Identified opportunities for cost reduction in laboratory operations without compromising on safety or reliability.
• Developed, scaled up and commercialized -Thyroxine Supplement (Narrow therapeutic index drugs and highly variable,unstable drugs) (USA, Europe, Australia)
• Successfully developed robust and bioequivalent formulation of BCS class I, II and III by QbD approach for US territory and execution of Pilot/Pivotal bio batch. 1)MUPS: (Antibiotic)2) IR tablets (Three Active combination)
• Supporting work for other products: Query response for US and Europe
• Exposure of ophthalmic formulation development: Two drug combination antibiotic.
• Regulatory Market: USFDA (USA), MHRA (UK), EMA (Europe)
• Design and conduct pre-formulation, formulation, process, stability, and container closure development studies for drug products
• Apply scientific fundamentals to solve formulation, stability issues.
• Develop working relationships with internal colleagues.
• Prepare professional technical reports, presentations, and documents for regulatory submissions.
• Evaluate functional activities for projects and provide appropriate timelines/resource requirements; executes plans, and coordinate activities in functional area; keep functional activities on schedule.

• Development of products for ANDA market as per the requirement.
• Deliver the products along with the relevant documentation within the time frame.
• Formulation development as per Quality by Design (QbD) using Design of Experiments (DOE).
• Screening new opportunities for formulation development Literature search, patent interpretation and development of patent non-infringing formulations.
• Bio-assessment reports, review of Bio-study protocols and assessment of Bio-results.
• Preparation of quality target product profile, critical quality attributes, critical material attributes, critical process parameters and control strategy documents. Risk assessment of material attributes and process parameters with respect to critical quality attributes of drug product. To provide inputs/recommendations for risk mitigation plans.
• Scaling up of different processes and preparation and review of control strategy for process control.
• Review and provide guidance to team members for all above listed activities.
• Preparation of Product development report with respect to flow of information from development knowledge.
• A supporting role in all departmental activities, coordination within the department and other departments within the campus and outside.
• Successfully developed BCS Class I and II product by QbD approach for US and Europe territory.