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.