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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in scaling manufacturing operations from R&D to commercial production, with a strong focus on quality management systems and regulatory compliance. Proven ability to lead technology transfer, manage supply chain logistics, and optimize manufacturing processes for high-volume production.
Highest-signal resume keywords
Manufacturing Operations ManagementTechnology Transfer LeadershipQuality Management Systems (QMS)Supply Chain and Logistics ManagementCost Modeling and Financial Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Manufacturing Performance MetricsProcess OptimizationProduction ScalingMaterial SourcingSupplier Relationship ManagementRegulatory ComplianceProcess ValidationAutomationLine RedesignInventory Operations
Soft Skills
Cross-Functional CollaborationCustomer Satisfaction FocusProblem SolvingPeople Management
Industry Keywords
Class II Medical DeviceClass III Medical DeviceRegulated EnvironmentCombination ProductsMaterial Science & Technology TransferOperational InfrastructureManufacturing QualityFulfillment OperationsCustomer-Facing OperationsLate-Stage Clinical Production
About the role
Key responsibilities & impact- Serve as the primary relationship owner and day-to-day point of contact for CMO partners
- Lead technology transfer from R&D to clinical and commercial manufacturing
- Oversee late-stage clinical and commercial production across product lines
- Drive manufacturing performance metrics including yield, throughput, and product quality
- Support CMO selection and onboarding, including process validation and scale-up
- Build and manage supply chain, logistics, fulfillment, and inventory operations
- Own material sourcing and supplier relationships
- Identify critical dependencies and build supplier redundancy to mitigate risk
- Build the manufacturing line from the ground up with a path from approximately 10K to approximately 1M units per month
- Drive automation, process optimization, and line redesign as production scales
- Own manufacturing cost modeling and financial planning for operations
- Develop sourcing strategy and budget frameworks with finance and leadership
- Establish systems and processes to support future team growth and internal manufacturing capabilities
- Ensure manufacturing quality, regulatory compliance, and adherence to QMS
- Partner cross-functionally with leadership, formulation, device, and quality teams
- Contribute to customer satisfaction through reliable product delivery and issue resolution
Requirements
What you’ll need- Proven experience scaling a product from R&D to commercial manufacturing in a regulated environment
- Experience overseeing manufacturing operations for a Class II or III medical device or equivalent regulated product
- Hands-on experience scaling production volumes significantly (e.g., 10x or more)
- Direct experience working with CMO partners including selection, onboarding, and tech transfer
- Experience managing supply chain, logistics, inventory, and fulfillment operations
- Familiarity with Quality Management Systems (QMS) in regulated environments
- Demonstrated ability to lead technology transfer and process scale-up
- Experience with manufacturing cost modeling and financial planning
- Direct people management experience
- Some travel required, approximately 10%-30%
- Preferred: Experience with combination products; background in Material Science & Technology Transfer (MSNT); experience scaling to 100K+ units per month; experience across cosmetic and medical device products; experience with automation and line redesign; customer support or customer-facing manufacturing operations; experience managing managers or building multi-layered organizations; experience implementing or optimizing operational infrastructure
Benefits
Comp & perks- Equity in the form of Stock Options
- Robust Health Insurance includes Medical, Dental, Vision
- Life, AD&D, and Short-Term Disability Insurance
- In-person company events
- Fully-stocked kitchen
- In-office lunch twice a week
- Working with a world-class team in technology and healthcare on the most innovative solutions
- Paid time off and Paid Company Holidays
