Cynthia Provencher
Experienced Leader in Vendor Management and External Manufacturing & Operations
- Role
- Director, External Manufacturing (until Nov 2023) at Avrobio
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Cynthia Provencher
Experienced leader in vendor management and external manufacturing/operations, skilled in…
Experience
Director, External Manufacturing (until Nov 2023)
Jan 2021 — Present · Cambridge, MA, US
Oversaw all activities at contract manufacturing organizations (CMOs) to ensure on-time delivery of gene therapy products for rare and severe genetic diseases- Provided coordination and oversight of CMO activities for on-time product delivery- Building strong working relationships with CMOs and other vendors, providing technical guidance and quick issue resolution- Established business processes for external CMC partner management- Set priorities for matrixed teams to achieve program objectives- Provided front-line support for issue resolution in drug product manufacturing- Developed and negotiated critical contracts with CMO partners- Took accountability for contract execution and performance with external partners- Collaborated with internal AVROBIO teams, including AS & T, Quality Assurance, Supply Chain, CMC, Apheresis Ops, and Regulatory- Represented External Manufacturing in CMC Subteam meetings to provide input and insight into strategic decisions and manage conflicting timelines and deliverables
Education
University of New Hampshire
Bachelor's Degree
Skills
- Gmp
- Biotechnology
- Capa
- R&D
- Medical Devices
- Cross-Functional Team Leadership
- Fda
- Change Control
- Sop
- Quality System
- Validation
- Technology Transfer
- 21 Cfr Part 11
- Biopharmaceuticals
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- U.s. Food and Drug Administration (Fda)
- Corrective and Preventive Action (Capa)
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