• Identified, evaluated, and executed strategic growth opportunities through M&A, partnerships, and financing• Led due diligence efforts, including financial and legal analysis, to assess the feasibility and potential risks of transactions• Negotiated deal terms and agreements to ensure mutually beneficial outcomes• Developed and executed strategic plans to integrate acquired companies, manufacturing facilities, and technologies into the existing business • Provided guidance and… Show more • Identified, evaluated, and executed strategic growth opportunities through M&A, partnerships, and financing• Led due diligence efforts, including financial and legal analysis, to assess the feasibility and potential risks of transactions• Negotiated deal terms and agreements to ensure mutually beneficial outcomes• Developed and executed strategic plans to integrate acquired companies, manufacturing facilities, and technologies into the existing business • Provided guidance and support to senior leadership to inform strategy and decision-making Show less

• Led supply chain design (drug substance, drug product and packaging) for critical pipeline vaccines. Evaluated internal builds vs. CMO options to deliver low cost, on-time, and tax-enabled siting recommendation. Modeled uncertainties in demand, early-stage manufacturing process and capital costs to perform siting options analysis.• Leader for long-term strategy of drug product network. Led a cross-functional team from Marketing, Finance and Engineering to support growth of mature… Show more • Led supply chain design (drug substance, drug product and packaging) for critical pipeline vaccines. Evaluated internal builds vs. CMO options to deliver low cost, on-time, and tax-enabled siting recommendation. Modeled uncertainties in demand, early-stage manufacturing process and capital costs to perform siting options analysis.• Leader for long-term strategy of drug product network. Led a cross-functional team from Marketing, Finance and Engineering to support growth of mature pediatric vaccine portfolio and replacement of aging manufacturing assets. Prepared business case presentations for Executive Capital Review Committee.• Developed sourcing strategy for components and raw materials for COVID vaccines by collaborating with process development, procurement, and operations teams. Balanced the need for securing supply of materials vs. maintaining flexibility to adapt to an evolving manufacturing process.• Collaborated with regulatory, external manufacturing, and project management teams to create 10-year staffing & execution forecast to address critical drug product network expansion activity (5+ new manufacturing sites) using complex demand data & local market regulatory requirements.• Re-built previously strained relationship with strategic external partner for new vial component commercialization. Drove decisions at joint executive steering committee to balance need to deliver on supply agreement with partner & address expansion activities.• Spearheaded divestiture of medically significant product to a new biotech company, ensuring uninterrupted supply during transition. Show less

• Led new vaccine development business case to mitigate potential lost revenue of existing vaccines due to external pressures to reduce dosing regimen. Created business case based on market researchfrom 12 priority markets to quantify potential lost revenue vs. commercial viability of new vaccine. The outcome was acquisition of external technology to accelerate discovery efforts for new vaccine.• Identified new growth drivers for vaccine franchise in emerging markets by designing KPIs… Show more • Led new vaccine development business case to mitigate potential lost revenue of existing vaccines due to external pressures to reduce dosing regimen. Created business case based on market researchfrom 12 priority markets to quantify potential lost revenue vs. commercial viability of new vaccine. The outcome was acquisition of external technology to accelerate discovery efforts for new vaccine.• Identified new growth drivers for vaccine franchise in emerging markets by designing KPIs to measure ability of local marketing teams to increase vaccination coverage rates based on socioeconomic factors and health care budgets.• Piloted HPV disease awareness and vaccination campaign within 8 targeted Merck commercial offices and manufacturing sites toserve as a case study for marketing team to engage other multi-national corporations in providing vaccines for their employees. Show less

•Developed and scaled up direct compression drug product manufacturing process of a new product by employing design of experiments (DoE) and multidimensional data analysis to map acceptable process design space. •Authored the film coating process development section of the NDA regulatory filing for a new product using a Quality-by-Design (QbD) approach to demonstrate a deeper understanding of the process. •Closely collaborated with the commercial site at Heist, Belgium to lead the… Show more •Developed and scaled up direct compression drug product manufacturing process of a new product by employing design of experiments (DoE) and multidimensional data analysis to map acceptable process design space. •Authored the film coating process development section of the NDA regulatory filing for a new product using a Quality-by-Design (QbD) approach to demonstrate a deeper understanding of the process. •Closely collaborated with the commercial site at Heist, Belgium to lead the preparation and right first time execution of validation batches for a new product. These efforts ensured the project will meet the timelines for File on Time (FOT) and Launch on Time (LOT). Show less

Department: Global Technical Operations, Pharm Shared Services (Aug 2014 - Jul 2015)Location: West Point, PA•Developed an Integrated Process Robustness strategy for the Top 40 Products' drug product and drug substance manufacturing sites to capture and understand signals that led to earlier actions to reduce deviations, discards and other production disruptions.•Created an interactive and user friendly web-based interface that instantly provides statistical process control… Show more Department: Global Technical Operations, Pharm Shared Services (Aug 2014 - Jul 2015)Location: West Point, PA•Developed an Integrated Process Robustness strategy for the Top 40 Products' drug product and drug substance manufacturing sites to capture and understand signals that led to earlier actions to reduce deviations, discards and other production disruptions.•Created an interactive and user friendly web-based interface that instantly provides statistical process control charts of manufacturing CQA data and other robustness signals (i.e. supply chain maps, robustness issues, process capability index) in Spotfire®. Department: Chemical Process Development and Commercialization (Aug 2013 - Jul 2014)Location: Rahway, NJ•Developed and scaled up chemical manufacturing processes for an Active Pharmaceutical Ingredient (API) to supply Phase III clinical studies and FSS studies on critical path.•Transferred and managed the crystallization step of a key intermediate by an external manufacturer to ensure their campaign delivered on time in full.•Developed a thermodynamic model in DynoChem to predict the rate of sulfur dioxide removal from a reaction mixture based on multiple scale-up factors.Department: Vaccine Manufacturing Science and Commercialization (Aug 2012 - Jul 2013)Location: West Point, PA•Analyzed single-use depth filter candidates as replacement for tangential flow microfiltration (MF) filters for primary cell clarification step in the purification process of a vaccine to enable easier tech transfer to emerging markets that can’t support high utility burdens of stainless steel skids. •Executed process change support for a vaccine by developing a representative lab scale system and demonstrating equivalence of new and old chromatography resins to prevent the need for full-scale manufacturing of demonstration batch and potential discards. Show less

Established protocols for high throughput screening of Aqueous Two Phase Systems (ATPS) using automated liquid handler (TECAN Freedom Evo 200) to characterize phase partitioning behavior. Evaluated scalability, cost, sterility and other application-based factors of ATPS.

Used molecular dynamics simulation to develop a predictive relationship between the structural and molecular properties of proteins and their propensity to unfold while absorbed to chromatographic surfaces.

Maintained and updated intranet databases pertaining to critical documents regarding federal research grants.