Benefits:
Competitive salary
Health insurance
Opportunity for advancement
Operations & Manufacturing Manager
Lavior Pharma is seeking an experienced Operations & Manufacturing Manager to oversee manufacturing operations, supply chain management, and regulatory coordination.
This role will manage contract manufacturers (CDMOs), suppliers, and production planning while ensuring manufacturing operations comply with ISO 13485 quality standards and FDA regulatory requirements.
The Operations & Manufacturing Manager will play a key role in scaling Lavior’s manufacturing capabilities while maintaining regulatory compliance and operational efficiency.
This position reports directly to the CEO.
Key Responsibilities:
Manufacturing & CDMO Management
Serve as the primary operational liaison with contract manufacturers (CDMOs).
Oversee production planning, batch scheduling, and manufacturing timelines.
Monitor manufacturing performance including lead time, yield, and cost efficiency.
Ensure manufacturing documentation, batch records, and traceability systems are maintained and audit-ready.
Support scale-up initiatives and process improvements.
Supplier & Contract Manufacturer Sourcing
Identify, evaluate, and onboard new contract manufacturers, CDMOs, and production partners.
Source and qualify new suppliers and vendors for manufacturing components and raw materials.
Manage sourcing for production materials including:
tubes
packaging
boxes
printed materials
components and labeling
Conduct supplier qualification and coordinate quality agreements.
Perform supplier performance reviews and maintain approved supplier lists.
Supply Chain & Production Planning
Develop production forecasts and manufacturing plans aligned with company growth.
Coordinate procurement and inventory planning to ensure supply availability.
Manage lead times, logistics, and supplier performance.
Implement systems to improve manufacturing efficiency and supply chain reliability.
Cost Optimization & Pricing Support
Analyze manufacturing costs and identify opportunities for cost optimization.
Support leadership in product pricing strategy and margin improvement.
Evaluate alternative suppliers and manufacturing processes to reduce costs while maintaining quality standards.
Quality & ISO 13485 Compliance
Support and maintain manufacturing operations aligned with ISO 13485 Quality Management System requirements.
Ensure CDMOs and suppliers comply with quality standards and documentation requirements.
Assist in implementing SOPs, CAPA processes, and quality documentation.
Support preparation for quality audits and regulatory inspections.
Regulatory & FDA Coordination
Coordinate testing with FDA-compliant laboratories, including:
biocompatibility testing
assay validation
stability testing
medical device product testing
Support regulatory activities including:
FDA 510(k) submissions
OTC regulatory requirements
21 CFR Part 211 (pharmaceutical GMP)
21 CFR Part 820 (medical device QSR)
Logistics & Operations
Coordinate product logistics and supply chain operations.
Ensure inventory availability to support U.S. and international growth.
Implement operational processes that support scalable manufacturing.
Required Experience
5–10+ years experience in manufacturing operations, supply chain, or production management.
Experience working with contract manufacturers (CDMOs).
Experience sourcing and qualifying new suppliers and manufacturers.
Experience in medical devices, pharmaceuticals, OTC products, or regulated skincare manufacturing.
Technical Knowledge
Production planning and manufacturing operations
Supply chain management and procurement
ISO 13485 quality systems
FDA regulatory frameworks including:
510(k)
OTC compliance
21 CFR 211 and 820
Education
Bachelor’s degree in one of the following:
Biomedical Engineering
Chemical Engineering
Industrial Engineering
Pharmaceutical Sciences
Supply Chain / Operations Management
Advanced degree or ISO 13485 / regulatory certification is a strong advantage.
Key Skills
Manufacturing process optimization
Vendor negotiation and supplier qualification
Regulatory and quality compliance
Production forecasting and planning
Cost optimization and margin management
Cross-functional leadership
Why Join Lavior
Work with innovative botanical-based medical technologies
Help scale a company entering global markets
Build and optimize manufacturing infrastructure
Work directly with executive leadership to drive operational growth