Production Supervisor

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Production Supervisor in Irvine, CA who possesses: Bachelor's degree preferred 3+ years of production supervisory experience and operations-related functions Knowledge of industry-standard practices in the medical device industry or other regulated industries Strong people management experience with the ability to lead, coach, and develop production teams FULL DESCRIPTION: We are seeking a Production Supervisor to lead second-shift THV production operations in a medical device cleanroom manufacturing environment. This onsite role is responsible for supervising production team resources across tissue processing, valve assembly, solutions mixing, and tool cleaning while supporting commercialization of transcatheter heart valves. The ideal candidate will have production supervisory experience, strong people management skills, regulated manufacturing experience, and the ability to drive safety, quality, throughput, compliance, continuous improvement, and team development in a fast-paced second-shift environment. The selected candidate will be responsible for: Leading second-shift production team resources for THV operations Supervising tissue processing, valve assembly, solutions mixing, and tool cleaning areas Supporting new product development and commercialization of transcatheter heart valves Planning, organizing, controlling, and supervising the manufacturing process Leading production staff through coaching, mentoring, performance feedback, and team development Monitoring and evaluating job performance while promoting team morale and cross-functional collaboration Managing attendance, behavioral matters, performance expectations, and daily team accountability Providing technical support for production processes, including troubleshooting process issues and guiding staff on procedures Supporting product evaluation and disposition decisions while ensuring processes are performed according to established requirements Coordinating completion of production tasks by planning schedules, aligning resources, and ensuring materials, equipment, and personnel are prepared Coordinating solutions mixing activities, including verifying required materials and equipment and aligning schedules with production needs Monitoring inventory levels and coordinating with supply chain and procurement teams to maintain appropriate stock levels Supporting demand forecasting based on production schedules Monitoring, maintaining, and driving performance against production KPIs and operational metrics Tracking safety, quality, throughput, productivity, on-time delivery, efficiency, scrap, and attendance metrics Implementing corrective actions to ensure departmental goals are achieved Collaborating on investigations and corrective actions to improve quality issues Supporting manufacturing transfer-related activities in a team environment Championing change management throughout the manufacturing process Driving technical advancements with an emphasis on mistake-proofing, continuous improvement, procedure compliance, Six Sigma, and Lean principles Ensuring compliance with the Corporate Quality System Manual and GMP procedures Initiating and monitoring training programs related to quality system and GMP compliance Maintaining a safe, clean, and secure working environment by establishing and enforcing procedures, rules, and regulations Supporting the development of group leads and second-shift team growth Making sound production decisions independently during second-shift operations Collaborating with Engineering, Quality, Manufacturing, and cross-functional teams Performing other duties as assigned The selected candidate will also possess: Bachelor's degree preferred 3+ years of production supervisory experience and operations-related functions required Medical device industry experience strongly preferred Regulated industry experience required Pharmaceutical manufacturing experience may be considered Knowledge of industry-standard practices in medical device or other regulated industries required Experience working in cleanroom manufacturing environments preferred Experience with tissue processing, valve assembly, line assembly, solution mixing, or similar regulated production processes preferred Experience supervising second-shift, off-shift, or independently operating production teams preferred Ability to lead, coach, mentor, and develop production employees Ability to manage attendance, performance, behavioral issues, and team accountability Ability to support a team of approximately 15+ employees Experience working and collaborating within cross-functional teams Experience taking initiative and performing hands-on work Experience implementing Lean Manufacturing and Six Sigma concepts preferred Strong attention to detail Ability to work in a fast-paced environment Results orientation, accountability, and project ownership Strong hands‑on skills with the ability to apply technical knowledge and judgment to complex technical problems Knowledge of Microsoft Office Suite Excellent communication and interpersonal skills Strong collaboration skills with cross-functional stakeholders Ability to make decisions on the spot and support production needs independently Ability to train on first shift for approximately the first 2 months Ability to work second shift, approximately 2:30 PM to 11:00 PM Ability to work onsite in Irvine, CA Physical Requirements: Ability to perform duties in both office and manufacturing environments Ability to work in a cleanroom manufacturing environment while following applicable gowning, safety, quality, and GMP procedures Ability to stand, walk, bend, reach, and move throughout production, cleanroom, office, and manufacturing areas as needed Ability to sit and work at a computer for extended periods while reviewing production schedules, KPIs, quality records, training records, reports, and production documentation Ability to communicate by phone, email, video meeting, and in person throughout the workday Ability to visually inspect production areas, manufacturing activities, production documentation, quality records, and computer screens as needed Ability to support production activities involving tissue processing, valve assembly, solutions mixing, and tool cleaning areas Ability to occasionally lift, carry, or move standard office, production, or manufacturing materials as needed Ability to work around regulated medical device manufacturing processes, production equipment, and cleanroom materials Ability to wear required personal protective equipment and cleanroom gowning as needed Ability to work second-shift operating hours and occasional additional hours as business needs require Salary Range: $96,000 to $107,000/year plus 12.5% annual bonus More information can be found at #J-18808-Ljbffr Simply Biotech