GMP Operations Leader: Cleanroom & Lab Scale-Up

New Horizon Medical Solutions LLC.; Simi Valley (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

New Horizon Medical Solutions LLC. is seeking an Operations Manager to lead GMP cleanroom operations and laboratory manufacturing in a startup‑scale setting in Los Angeles.

The role is hands‑on, requiring direct work in controlled environments while building compliant, scalable processes to support rapid growth and client programs. You will oversee facility operations, lead a growing team, ensure cGMP compliance, and work with Quality on deviations, CAPAs, and audits.

Qualifications

• Bachelor’s degree in operations management, business, engineering, pharmaceutical science or related field.
• Minimum 10 years’ experience with 3–5 years in operations or production management 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.

Responsibilities

• 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.
• 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.

Skills

GMP cleanroom operations

Aseptic technique

Lean Manufacturing / Six Sigma

Leadership / team management

Documentation & SOPs

Education

Bachelor’s degree in operations management / engineering / pharmaceutical science

Job description

New Horizon Medical Solutions LLC. is seeking an Operations Manager to lead GMP cleanroom operations and laboratory manufacturing in a startup‑scale setting in Los Angeles.

The role is hands‑on, requiring direct work in controlled environments while building compliant, scalable processes to support rapid growth and client programs. You will oversee facility operations, lead a growing team, ensure cGMP compliance, and work with Quality on deviations, CAPAs, and audits.