Sharmi Sengupta

Strategic thought partner and co-leader covering a portfolio of global cross-functional CMC technical development teams with various molecular formats, clinical phases, routes of administration, and levels of complexity to deliver the pipeline. Navigates teams through risk management, governance, portfolio review, and escalation processes. • Manage a multi-project CMC team responsible for three late stage bispecific development products involving high strategic complexity and competing priorities to successful completion of BLA/MA filing, launch, commercial tech transfers, and novel post approval filing pathways. • Strategic and insightful governance business partner to VPs of Large Molecule, Device, and Cell Therapy Development to ensure clear, efficient, and effective decision making to support successful progression of pipeline project milestones. • Instrumental lead in influencing, co-creating, and delivering an Early Stage Research-IND multi-project infrastructure and operating model. • Effectively mentored, coached, and delegated tasks to junior Project Managers to provide staff with the opportunity to develop new skills. • Facilitated cross-functional workshop involving SMEs and senior leaders to support organizational productivity goal of reducing FTE resource expenditure for registration enabling activities. • Successfully managed transfer of in-licensed late stage product while developing plans for BLA with minimal information available from external partner. • Strategized unprecedented non-platform accelerated ADC development plan and resource forecast in response to dynamic clinical results. • Enabled on-time delivery of company’s first small molecule inhalation combo product for Ph1 filing. • Led and reimagined departmental rotation program to manage, mentor, and develop candidates’ core project management skills in CMC environment.

Managed manufacturing operations team and served as SPOC for two partnering CROs to meet milestone of first patient screened for Ph2 adjuvant clinical trial. • Developed a communication plan to support the supply chain. • Introduced established technical development processes and tools to the iNeST team; adapted the tools to fit the needs of the team. • Partnered with Operational Excellence to design workshop to map the process for sample management and documentation.

Responsible for managing several large biotechnology accounts, linking strategy between key sites and locations, managing large development projects and initiatives, and maintaining mutually beneficial partnerships within the customer/supplier relationship. • Supported process development pipelines of key accounts by providing innovative Sartorius solution platforms, introducing newly launched products, and identifying continuous improvement opportunities. • Managed liaison for collaborative beta-testing and implementation of Sartorius technologies into key account drug development processes for large molecules. • Created and maintained a communication platform to coordinate and ensure internal resource allocations to key accounts based on well-defined priorities and business cases. • Led collaborative development workshops and white papers to create industry standards for defining functional specifications and multivariate analysis of single use technologies used within key accounts.

Coordinated cross-functional drug development project team meetings, ensured documentation of clear actions items, decisions, and agreements, and navigated corporate governance processes. Managed budget, scope, timelines, critical path, and milestones for projects in various stages of early development through commercial launch. • Managed generation and change control of Global Development Plans and Target Product Profiles. • Ensured adherence to ±5% variance for multi-million dollar annual project budgets and managed budget forecasting process. • Collaborated with project leads to analyze and identify project risks. Implemented appropriate mitigations. • Conducted gap analysis to identify key business drivers and strategic imperatives for post market activities in four therapeutic areas. • Led identification of key criteria questions and deliverables by Stage Gate, resulting in clear team objectives.

Managed action plans and timelines of four cross-functional project teams, ascertained alignment of deliverables across teams, communicated prioritization of activities, and ensured availability of resources. • Utilized Lean Six Sigma tools to lead process improvement initiatives. Improved turn-around time for sample analysis and documentation allowing for faster data driven decisions. • Managed $1M annual budget, provided quarterly/annual financial forecasting, and identified areas of potential savings. • Spearheaded planning workshops and ensured alignment of CMC team deliverables with Core Team objectives. • Led negotiations workshop, leadership training, and team building activities improving cross-functional relationships. Received “Key to Success” award for building collaborative and productive teams. • Initiated and facilitated numerous Voice of the Customer and problem solving sessions. Used DMAIC process to ensure a measureable improvement, resulting in Award for Excellence. • Managed the development of a Biologics process development toolkit which identified key work packages and deliverables resulting in more comprehensive plans, thereby minimizing rework.

Supported the development and scale-up of a robust protein purification process for clinical manufacture of drug substance. Drafted technical experimental protocols and reports necessary for HA filing in accordance with internal governance documents and regulatory requirements. • Planned and led several key experiments to completion and met organizational process characterization and validation milestones. • Developed batch records and trained manufacturing personnel for technology transfer from R&D to clinical manufacturing. • Ensured robustness of developed process by completing risk analysis using FMEA model. • Initiated and led Kaizen events to streamline document review and sample analysis process. • Received three Awards for Excellence for identifying and implementing multiple measures increasing safety of personnel.

Managed waste and hazardous materials transport under CFR – 49 (DOT), IATA, Federal, California, and European Union regulations. Analyzed product development process including materials balance, risk analysis, environmental and regulatory impacts. • Collaborated in job hazard analysis for facility employees according to OSHA regulations. • Evaluated water balance of two existing buildings for LEED Green Building certification. • Interpreted California Proposition 69 warning requirements, and ensured company compliance. • Reviewed greenhouse gas emission management strategies utilizing EPA’s Waste Wise tool contributing to EPA recognizing Allergan for Waste Wise Waste Prevention.

• Encouraged compliance and explained FDA regulations and standards to consumer groups, healthcare professionals, and state health authorities. • Compiled health education and outreach materials directed toward diverse communities. • Represented US FDA at various health fairs, conferences, and training sessions.

• Promoted prevention and primary intervention of childhood obesity, heart disease and stroke. • Recruited over 200 schools for participation in Jump Rope and Hoops for Heart fundraiser programs. • Designed marketing pieces and newsletters to encourage enlistment and participation.