Amanda Lewis
Director, CMC
- Role
- Director Oligonucleotide Cmc and External Manufacturing at Dyne Therapeutics
- Location
- Norton, MA, US
- LinkedIn followers
- 500 followers
About Amanda Lewis
Highly accomplished Associate Director, Chemistry, Manufacturing, and Controls (CMC) credited with 20+ years of progressive experiences, including delivery of manufacturing processes, biologics drug substance production, process characterization, design and execution of validation strategies, and continuous process verifications Expertise includes working with multiple types of drug substances, including mRNA, gene therapy, oligonucleotides, monoclonal antibodies, proteins, small molecules, and peptides, which provides a unique skill set and perspective in the CMC field Excellent serving as a technical subject matter expert regarding complex deviations and non-conformances Illustrate leadership driving solutions through collaborating within a team, investigating and identifying issues within manufacturing/impurity, and using resources to resolve problems adequately Lead and engage in collaborative communications with all members, partners, and levels while ensuring transparency of information and successfully administering strategy interactions and planning with contract manufacturing partners Successful sourcing and implementing eQMS (electronic quality management system), including authoring a Quality Manual and SOPs for managing outside contracts and collaborations, along with training internal users Author CMC sections of all regulatory documents, including IND amendments and NDAs, and report CMC strategy, progress, and challenges to executive management, and review and approve technical documentationCore Competencies Product Quality RequirementsRegulatory Submission SupportProcess ImprovementsDefine Control Strategy Manufacturing Operations Cross Functional Fluency Leadership/Team Player Regulatory Inspection Readiness Product Requirements Regional Regulatory RequirementsStakeholder Communications Product Development Lifecycle
Experience
Director Oligonucleotide Cmc and External Manufacturing
Apr 2025 — Present
Education
Union College
Environmental Studies
The Evergreen State College
BS, Chemistry
Colorado State University Global
Master of Science (M.S.)
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.