Production Supervisor - Second Shift

Cordis; Irvine (CA); On-site; USD 79,000 - 106,000; Full time

Job summary

Cordis, based in Irvine, seeks a Laboratory Supervisor to lead technicians and scientists in GMP/ISO-regulated development and manufacturing support for drug-device products.

Responsibilities include supervising lab operations, ensuring data integrity, and driving CAPAs, deviations, and audits. You will collaborate with R&D, Manufacturing, Quality, Engineering, and Regulatory teams, while promoting safety, training, and continuous improvement.

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Minimum 4 years of laboratory experience.
• Experience in GMP/GLP or ISO-regulated systems.

Responsibilities

• Lead, train, and mentor laboratory technicians and scientists.
• Oversee day-to-day laboratory activities and ensure adherence to procedures.
• Maintain data integrity; support investigations, deviations, CAPAs, and change controls.
• Collaborate with R&D, Manufacturing, Quality, Engineering, and Regulatory teams.
• Promote safety and continuous improvement in the lab.
• Support scale-up activities and technology transfers.

Skills

GMP/GLP knowledge

Supervisory experience

Documentation & data integrity

Lab safety & EHS

Communication & mentoring

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Materials Science, Biomedical Engineering, or related field

Tools

Particle size analysis

Microscopy

Laboratory equipment operation

Job description

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

Key Responsibilities

Team Management

• Supervise, train, and mentor laboratory technicians and scientists.
• Assign work, set priorities, and monitor performance against timelines and quality expectations.
• Conduct performance reviews and support development plans.
• Promote a culture of safety, accountability, and continuous improvement.

Laboratory Operations

• Supervise day-to-day laboratory activities, including formulation preparation, and control.
• Ensure adherence to approved procedures, protocols, and work instructions.
• Oversee use and maintenance of laboratory equipment (e.g., mixers, reactors, particle sizers, microscopes, refrigerators, etc.).
• Support method development, optimization, and transfer to manufacturing or pilot scale.
• Review laboratory data for accuracy, completeness, and compliance.

Quality, Compliance & Data Integrity

• Ensure compliance with GMP, ISO 13485, and internal quality system requirements.
• Enforce proper documentation practices, including batch records, lab notebooks, and electronic data systems.
• Participate in investigations, deviations, CAPAs, and change controls related to lab processes.
• Support internal and external audits and regulatory inspections.

Safety & EHS

• Ensure compliance with laboratory safety, chemical handling, and waste disposal requirements.
• Conduct or support safety training and risk assessments.
• Investigate and report safety incidents or near misses.

Cross-Functional Collaboration

• Collaborate with R&D, Manufacturing, Quality, Engineering, and Regulatory teams.
• Support scale-up activities and technology transfers.
  • Provide technical input to project teams and leadership.

Qualifications

Required Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Materials Science, Biomedical Engineering, or related field or the equivalent combination of education and experience.
• Minimum 4 years of laboratory experience.
• Experience working under GMP/GLP or ISO-regulated systems.

Preferred Qualifications

• 2+ years of supervisory or team-lead experience in a regulated laboratory environment.
• Experience in medical device or pharmaceutical manufacturing.
• ASQ or related analytical chemistry certification.

Key Competencies

• Familiarity with analytical tools (e.g., particle size analysis, microscopy, and efficiency testing).
• Understanding process development and scale-up principles.
• Proficient in documentation and electronic data systems.
• Strong people-management and coaching skills.
• Excellent communication and organizational abilities.
• Detail-oriented with strong problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.

Key Performance Indicators (KPIs)

• On-time completion of laboratory activities and projects
• Right-first-time documentation and data integrity compliance
• Reduction in deviations and rework
• Team training completion and competency levels
• Audit readiness and inspection outcomes

Working Conditions

• Laboratory environment with exposure to chemicals and particulate materials
• Requires use of PPE and adherence to safety protocols
• May require occasional extended hours to support projects or investigations

Pay / Compensation

The expected pre-tax pay rate for this position is $78,650 - $105,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.