Experience

Invivyd

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, Quality Control

  • Jan 2021 - Present

  - Hire and manage QC personnel including contractors, consultants, and vendors - Design and implement QC policies and strategies - Review and approve analytical qualification/validation protocols, reports, and SOP’s - Responsible for managing the release and stability testing of company product, including timely closure of laboratory investigations as necessary - Responsible for managing product specifications internally and externally with vendors - Point person for hosting and leading cross-functional and vendor meetings and interactions - Responsible for the qualification and inventory management of pre-clinical and cGMP reference standards and critical reagents - Participate and lead internal and/or external audits as necessary (onsite and remotely) - Author and review CMC regulatory documents - Manage QC budget and expenditures



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Quality Lead (Associate Director)

  • Dec 2018 - Jan 2021

  Experienced quality and technical professional with stewardship of quality strategy for clinical and commercial rare disease products. Lead local and global Quality cross functional teams and represent Quality functions in CMC forums to execute on program directives. Routine review and approval of worldwide regulatory submissions. Gatekeeper of product release and stability specifications. Experienced quality and technical professional with stewardship of quality strategy for clinical and commercial rare disease products. Lead local and global Quality cross functional teams and represent Quality functions in CMC forums to execute on program directives. Routine review and approval of worldwide regulatory submissions. Gatekeeper of product release and stability specifications.



Shire

• Lexington, MA

• Senior Scientist

  • Jan 2018 - Dec 2018

  Global Quality Lead for commercial & clinical rare disease pipeline (4 products). QC Liaison and Technical Representative for CMC and QbD activities. Global Quality Lead for commercial & clinical rare disease pipeline (4 products). QC Liaison and Technical Representative for CMC and QbD activities.



Momenta Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Analytical Scientist

  • Dec 2010 - Jan 2018

  Expanded analytical development knowledge and corresponding CMC activities. Expanded analytical development knowledge and corresponding CMC activities.



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Research Analyst

  • Jan 2003 - Dec 2010

  Gained laboratory and industry experience across three departments: Pre-Clinical, Quality Control, and Analytical Development. Gained laboratory and industry experience across three departments: Pre-Clinical, Quality Control, and Analytical Development.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manufacturing Technician

  • Jun 2001 - May 2002

  Supported the manufacturing of Cerezyme in a regulated GMP manufacturing facility. Supported the manufacturing of Cerezyme in a regulated GMP manufacturing facility.