Operations Manager – Pharmaceutical CDMO (Startup, GMP Cleanroom Operations)

Position Overview

We are a growing pharmaceutical CDMO seeking an Operations Manager to lead and scale GMP laboratory and cleanroom operations. This is a hands-on role for a leader who is comfortable working directly in controlled environments while building compliant, scalable processes in a startup setting.

The Operations Manager will oversee cleanroom operations, laboratory manufacturing activities, and operational systems, ensuring compliance with cGMP requirements while supporting client programs and rapid growth.

Key Responsibilities

Cleanroom & GMP Operations

• Oversee daily GMP cleanroom operations, including ISO-classified spaces
• Ensure proper gowning procedures, aseptic techniques, and contamination control
• Monitor and enforce cleanroom behaviors, environmental controls, and documentation
• Coordinate cleanroom cleaning, sanitization, and environmental monitoring activities
• Ensure proper material, personnel, and waste flow within controlled environments
• Support cleanroom readiness for client audits, FDA inspections, and internal audits

Operational & Team Leadership

• Lead, train, and supervise laboratory and production staff (10+ employees as the team scales)
• Establish and maintain SOPs, batch records, logbooks, and controlled documents
• Drive compliance with FDA, cGMP, and internal quality systems
• Partner with Quality on deviations, CAPAs, change controls, and investigations
• Support technology transfers, process scale-up, and contract manufacturing projects
• Manage equipment utilization, calibration, and preventive maintenance schedules
• Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives
• Assist with hiring, onboarding, budgeting, and vendor management in a startup environment

Minimum Qualifications

• Education: Bachelor’s degree in operations management, Business, Engineering, Pharmaceutical Science or related field
• Experience: Minium 10 years’ experience with 3–5 years of operations or production management experience in a highly regulated environment (medical device, biotech, pharmaceutical)
• Hands-on experience working in GMP cleanrooms or controlled laboratory environments
• Strong knowledge of aseptic technique and contamination control
• Familiarity with Lean Manufacturing and/or Six Sigma principles
• Proven experience supervising 10+ employees

Preferred Qualifications

• Experience in a pharmaceutical CDMO or CMO
• Direct involvement with FDA inspections and client audits
• Experience establishing cleanroom procedures in early-stage or startup facilities
• Six Sigma Green Belt or equivalent certification
• Strong documentation and training skills

Work Environment

This position operates in a warehouse environment in Los Angeles with regular interaction across departments (operations, logistics, administrative teams), requiring compliance with company policies and safety standards.

At-Will Employment & Equal Opportunity

This role is employed at-will — employment can be terminated by either party at any time with or without cause.

We are an Equal Opportunity Employer (EOE) committed to diversity and inclusion in the workplace.