Production Supervisor - Second Shift

Cordis•Irvine, CA

3d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.