Operations & Manufacturing Manager

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:

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:

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.

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:

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

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