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

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

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

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.

We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self‑identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

Yes, I Have A Disability, Or Have A History/Record Of Having A Disability No, I Don’t Have A Disability, Or A History/Record Of Having A Disability I Don’t Wish To Answer