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

New Horizon Medical Solutions LLC.; Simi Valley (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental & vision

Paid time off & holidays

Professional development

Job summary

VictoGen seeks an Operations Supervisor to lead daily GMP laboratory and cleanroom operations in a startup‑like, high‑compliance environment. The role requires coordinating production activities, supervising staff (initially 3–10), and ensuring alignment with Quality and Operations leadership to maintain readiness and regulatory compliance.

Responsibilities include supervising daily GMP cleanroom activities, attending to SOPs and batch records, and supporting audits (FDA, client, internal).

Qualifications

• Bachelor’s degree and 5–7 years in pharmaceutical/regulated manufacturing.
• 2–3 years in a lead or supervisory role.
• Hands-on experience in GMP cleanrooms or controlled environments.
• Strong understanding of cGMP (FDA, USP) requirements.
• Experience following and enforcing SOPs and documentation practices.

Responsibilities

• Supervise daily GMP cleanroom operations and ISO-classified environments.
• Ensure gowning, aseptic technique, and contamination control adherence.
• Monitor environmental conditions and documentation accuracy; manage schedules for cleaning and environmental monitoring.
• Supervise 3–10 staff; provide hands-on training and performance feedback.
• Coordinate with Quality on deviations, CAPAs, change controls, and investigations.
• Support technology transfer and manufacturing activities for client programs.

Skills

Team supervision

GMP knowledge

Aseptic technique

Documentation practices

Lean/Continuous Improvement

Education

Bachelor’s degree in Operations, Engineering, Life Sciences, or related field

Job description

VictoGen is committed to delivering high-quality products and services that meet or exceed customer expectations through a strong focus on operational excellence, continuous improvement, and regulatory compliance. Our success is driven by a culture of accountability, integrity, and employee commitment to quality at every level of the organization.

At VictoGen, we value collaboration, precision, and purpose. Each team member plays a meaningful role in upholding our standards, supporting our customers, and contributing to a safe, compliant, and high-performing workplace.

Position Overview

We are a growing pharmaceutical CDMO seeking an Operations Supervisor to support and oversee daily GMP laboratory and cleanroom operations. This is a hands‑on role for a working supervisor who thrives in a startup environment and is comfortable leading frontline operations while ensuring compliance with cGMP standards.

The Operations Supervisor will be responsible for coordinating daily production activities, supervising staff, and maintaining operational readiness of cleanroom environments while partnering closely with Quality and Operations leadership.

Key Responsibilities

Cleanroom & GMP Operations

• Supervise daily GMP cleanroom operations, including ISO-classified environments
• Ensure adherence to gowning procedures, aseptic techniques, and contamination control practices
• Monitor cleanroom behaviors, environmental conditions, and documentation accuracy
• Coordinate cleaning, sanitization, and environmental monitoring schedules
• Ensure proper material, personnel, and waste flow within controlled environments
• Support audit readiness activities including FDA inspections, client audits, and internal audits

Operations & Team Supervision

• Supervise and support laboratory and production staff (initially 3–10 employees)
• Provide hands‑on training, coaching, and performance feedback to team members
• Execute SOPs, batch records, logbooks, and controlled documentation processes
• Partner with Quality on deviations, CAPAs, change controls, and investigations
• Support technology transfer and manufacturing activities for client programs
• Monitor equipment usage, coordinate calibration, and support preventive maintenance
• Identify opportunities for process improvements and support Lean initiatives
• Assist with onboarding and day‑to‑day workforce coordination

Minimum Qualifications

• Education: Bachelor’s degree in Operations, Engineering, Life Sciences, or related field (or equivalent experience)
• Experience:
• Minimum 5–7 years in pharmaceutical, biotech, or regulated manufacturing environment
• Minimum 2–3 years in a lead or supervisory role
• Hands‑on experience working in GMP cleanrooms or controlled environments
• Working knowledge of aseptic technique and contamination control
• Strong understanding of cGMP requirements (FDA, USP standards)
• Experience following and enforcing SOPs and documentation practices

Preferred Qualifications

• Experience in a pharmaceutical CDMO/CMO environment
• Exposure to FDA inspections or client audits
• Experience in startup or early‑stage manufacturing environments
• Familiarity with Lean Manufacturing or continuous improvement methodologies
• Strong documentation, training, and cross‑functional communication skills

Physical & Work Environment Requirements

• Ability to stand, walk, sit, bend, reach, and move throughout the facility as needed.
• Ability to lift and carry up to 25 pounds and occasionally up to 50 pounds with assistance, as appropriate.
• Ability to work in office, manufacturing, warehouse, and/or controlled environments.
• Ability to wear required personal protective equipment (PPE).
• Ability to safely work around manufacturing equipment and operational areas.
• Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

At-Will Employment Statement

Employment with VictoGen is at will, which means that either the employee or VictoGen may terminate the employment relationship at any time, with or without cause or notice, in accordance with applicable law.

VictoGen is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, veteran status, or any other protected characteristic under applicable federal, state, or local laws.

Compensation is commensurate with experience, qualifications, and job scope.

VictoGen offers a competitive benefits package which may include:

• Medical, dental, and vision insurance
• Paid time off, holidays, and sick leave
• Professional development and training opportunities
• Additional benefits based on role and eligibility

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