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.
• 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.

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.
• 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.

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

• 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+)