GMP Operations Leader: Cleanroom & Lab Scale-Up

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 clean rooms or controlled laboratory environments
• Strong knowledge of aseptic technique and contamination control
• Familiarity with Lean Manufacturing and/or Six Sigma principles

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

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.

First name

Last name

Email address

Location

Phone number

Resume Attach resume

Attach another file Attach file

What is your Linkedin Profile URL?

What is the name of your current employer?

What are your salary requirements? per hour

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?

Do you have seven (7) or more years experience working in Biotech AND GMP environments? Yes No

We invite you to complete the optional self-identification questions below used for compliance with government regulations and…