Operations Manager - Pharmaceutical CDMO (Startup, GMP Cleanroom Operations) VictoGen Pharma Simi Valley, CA Job Details Full-time $125,000 - $155,000 a year 16 hours ago Qualifications Manufacturing management Team leadership Contamination control Cleanroom protocols Managing laboratory teams Supervising experience Bachelor's degree Pharmaceutical company experience Laboratory techniques Sterile attire donning Managing manufacturing teams Business operations Pharmaceutical manufacturing facility experience Full Job Description 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.