Michael R. Email & Phone Number

Boston, Massachusetts, United States

• CMC sub-team member, and technical team lead for multiple development projects.• Manager seeking to improve my ability to coach and grow the people on my teams. • Working cross-functionally with IT to modernize the software and data ecosystems our scientists use.• Currently building a team to leverage typical data science skill sets in helping our process chemists, analysts, chemical engineers, and formulators across Pharmaceutical Sciences do their work more efficiently, provide… Show more • CMC sub-team member, and technical team lead for multiple development projects.• Manager seeking to improve my ability to coach and grow the people on my teams. • Working cross-functionally with IT to modernize the software and data ecosystems our scientists use.• Currently building a team to leverage typical data science skill sets in helping our process chemists, analysts, chemical engineers, and formulators across Pharmaceutical Sciences do their work more efficiently, provide automations, enable and implement new technologies, and better leverage our experimental data. Show less

Boston

• Represent drug substance development (Process Chemistry & Engineering) on CMC Sub-teams • Develop functional area strategy to effectively manage risk and execute on project objectives for multiple clinical assets. • Manage multiple external CMO/CRO partners and internal recourses to achieve project goals in coordination with the cross functional project team. While in this role I began developing human centered design skills (completed an internal innovation program) and… Show more • Represent drug substance development (Process Chemistry & Engineering) on CMC Sub-teams • Develop functional area strategy to effectively manage risk and execute on project objectives for multiple clinical assets. • Manage multiple external CMO/CRO partners and internal recourses to achieve project goals in coordination with the cross functional project team. While in this role I began developing human centered design skills (completed an internal innovation program) and sought to adopt tools that drive a culture of customer/user centered innovation on my teams. I've found success adapting and implementing elements of the "agile" framework on my projects. Show less

Boston, Ma

• Designed and executed elaborate and technically challenging experiments• Interpreted complicated multi-dimensional data to form recommendations for new process and development directions• Effectively multi-tasked to manage efforts on multiple activities and projects • Expected to innovate on technical methodology to improve outcomes and achieve results• Imported new principles and/or concepts from other fields to develop useful new experimental approaches • Championed… Show more • Designed and executed elaborate and technically challenging experiments• Interpreted complicated multi-dimensional data to form recommendations for new process and development directions• Effectively multi-tasked to manage efforts on multiple activities and projects • Expected to innovate on technical methodology to improve outcomes and achieve results• Imported new principles and/or concepts from other fields to develop useful new experimental approaches • Championed relevant emerging technology in my field • Managed and coordinated a $2+MM CapEx budget for Pharmaceutical Sciences.My team was a finalist for the Vertex Outstanding Research Achievement Award, recognizing our work to substantially reduce the cost of goods for a clinical candidate and simplify the supply chain through the development of an alternative raw material synthetic route. We estimated the savings for the commercialized process at $80 million per year. Show less

• Conducted the optimization of a multi-step process for a Phase III clinical candidate • Responsible for generating “Quality by Design” data packages including design space mapping, robustness testing, impurity tracking, and process modelling. • Rapidly synthesized multi-gram quantities of various process impurity markers to support the project. • Core team member for the implementation and maintenance of a cross functional electronic notebook used in Pharmaceutical Development.

- Lab scale (100g - Kg) GMP production of API and intermediates.- Experience with large scale separations using PrepHPLC- Trained to work safely with High Potency compounds (Category 3+)