Sarita Mohan Pavaskar

Management of an overall project plan for multiple projects simultaneously undergoing lab development, technology transfer, scale-up, and FDA submissions and approvals, serving as intermediary between stakeholders and team members to ensure all project requirements, risks and deliverables are identified, integrated, and tracked throughout project lifecycle, from initiation through closure to ensure timely completion and success

Key Roles & Achievements

• Simultaneously provided PM services to an average 15 drug development programs at various stages by prioritizing tasks according to urgency and alignment with organizational goals
• Facilitated regulatory submission discussions with RA and CFTs for New/Variation submissions and timely responses to the queries. Successfully ensured on time and upside regulatory submissions of 10 products for various markets
• Ensured compliance with industry standards and regulations and updates to project practices
• Collaborated with Regulatory, Portfolio, Product Management and Business teams and developed integrated product strategy to each market covering approvals and product launch plan
• Proactively identified potential project risks and developed mitigation strategies appropriately to address the challenges, took corrective actions as needed and arrived to decision at critical tasks
• Acted as a SPOC for internal and external stakeholders and monitored the progress of projects by establishing effective and timely communication among team members for enhanced collaboration and successful project completion
• Developed integrated project plans, identified and tracked milestones, meeting excellence (scheduling, agenda development, minutes, action items), managed project communications to stakeholders and team members (cadence and transparency)
• Maintained annual stage gate and deliverable grids to track and monitor individual project milestones
• Collaborated with leads of all functional groups to establish integrated project plans for each study
• Conducted daily/weekly LDMs to keep the project teams informed, focused and arriving conclusion/problem solving to achieve short term and long-term goals
• Prepared reports and dashboards using tools like Excel, MSP, PPT, Power BI to visualize project status including timelines, key milestones, achievements and risks
• Taken an additional responsibility of fixing annual vertical Score Card, GTP and overall projects budget estimation
• Demonstrated respect, friendliness and willingness to help wherever needed

Management of multiple customer-centric (CRO) projects, mainly from US and EU regions, to help life science companies advance their programs from discovery to commercialization, serving clients from project inception to consistently deliver value to customer, closely monitoring integrated discovery programs through a unified strategy, critical decision milestones and ensure program efficiency, timely communication, and rapid turnaround time.

Key Roles & Achievements

• Provided PM support to an average 10 client-based projects per year from US and EU regions with successful Hit identification
• Consistently surpassed productivity by maximizing utilization of available resources
• Provided on-going support to the delivery team on their project plan, delivery schedule, critical project milestones and identifying customer priority/ requirements
• Ensured effective execution by running review meetings through adequate agenda setting, capturing decisions and action item and by actively following up action items to completion
• Actively collaborated with Clients, BD, Quality, Finance, Logistics & Supply chain to ensure smooth execution of projects
• Led risk assessment meetings, enabling resolution of issues in a timely manner, and systematic closure of activities as required
• Met tight deadlines to satisfy client demands and project timelines

Managed project teams with primary responsibility for generic API manufacturing process design for complex and polymer products, technology transfer, validation activities, DMF filing & approvals and deficiency queries responses required to bring pharmaceutical products to market

Key Roles & Achievements

• Managed overall project life cycle starting from ideation till FDA submission and query response for 3 complex polymer products with a team of 3 Scientists
• Filed the 1st NCE-1 complex polymer product of Solara in a stipulated timeline
• Coordinated with IPM-team for the legal aspects & new patent filing and with quality & RA teams during the process design to meet the regulatory aspects of the API for DMF filing
• Fixed the quality norms RMs, intermediates and finished products, including non-pharmacopeia products, with scientific rationale for the proposed limits in compliance with quality and RA
• Literature search (Scifinder, Google patents), ROS screening, RMC for discussion with the stakeholders, running cost improvement programs, discussion with procurement team for RM sourcing efficiency and contribution in Make or Buy decision
• Provided detailed technical and operational direction in project challenges, consistently meeting the deliverables according to deadlines
• Explained highly complex information in terms easily understood by non-technical personnel
• Responded to the regulatory queries on time
• Conducted team member meetings and updated members on best practices and continuing expectations

Managed a team of 3 scientists with a key role of developing cost effective and commercially viable manufacturing process for the APIs meeting project timelines

Key Roles & Achievements

• Contributed in literature search, ROS screening & RMC evaluation for APIs, intermediates and CRAMS molecules
• Ensured process optimization and development of commercially viable manufacturing process for APIs in a given time line
• Collaborated with team for product Specification finalization with scientific rationale for the proposed limits in compliance with quality and RA
• Prepared product development report (PDR) and technology transfer to the scale up/manufacturing site.
• Involved in cost improvement programs with proper ideation to reduce the cost significantly by employing backward integration of KSMs and yield improvement.
• Developed safety awareness in working area to ensure Zero accident/incidents

• Planned and conducted the lab experiments independently assigned by the manager
• Structural elucidation through analytical tools- GC, HPLC, IR, NMR, MASS
• Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems
• Trained new employees on areas of technical expertise and compliance issues relevant to lab setting
• Implemented quality control measures to ensure the accuracy and reliability of experimental results
• Managed compliance with GLP and GMP norms