Production Manager

Life Science Outsourcing, Inc.•Brea, CA

1d•$75,000 - $90,000•Onsite

About The Position

Life Science Outsourcing, Inc (LSO) is seeking a proactive and enthusiastic Production Manager to lead operations on our Brea, California cleanroom floor. This hands-on leadership role involves planning work, directing the team, and continuously improving processes to meet customer commitments, quality standards, and financial targets. The Production Manager will lead group leaders and production employees, collaborate with various departments, and foster a culture of accountability, precision, and compliance within an FDA-regulated, ISO 13485-certified environment. The role requires ownership of daily production performance, from scheduling to team management and customer relations.

Requirements

Bachelor's degree in Operations Management, Industrial Engineering, Business Administration, or a related field preferred. An equivalent combination of education and direct production management experience will be considered.
Minimum 5 years of progressive manufacturing experience, with at least 3 years supervising or managing direct reports.
FDA-regulated, ISO 13485-certified medical device experience strongly preferred. Pharmaceutical or other regulated industry experience considered.
Track record of managing production schedules, hitting on-time delivery, and leading teams through performance improvement.
MRP/ERP experience required (familiarity with Deacom or similar a plus), plus proficiency with Microsoft Excel, Word, and Outlook.
Working knowledge of FDA 21 CFR Part 820 and ISO 13485 as they apply to production operations.
A leader who can develop and hold accountable a multi-level team of leads and hourly employees.
A clear communicator who turns floor realities into data-driven summaries for leadership, Quality, and customers.
A problem solver grounded in Lean, 5S, root-cause analysis, and CAPA.
Able to manage competing priorities in a fast-paced, customer-driven environment without sacrificing documentation quality or compliance.

Nice To Haves

Lean Six Sigma certification (Green Belt or higher) or equivalent structured problem-solving training.
Bilingual in English and Spanish for communication with the production workforce.
Experience leading production through a third-party regulatory audit (FDA, BSI, or equivalent).
Familiarity with cleanroom manufacturing protocols and ISO classification standards.

Responsibilities

Own the daily and weekly production schedule across all cleanroom and ancillary work centers, setting work order priorities to meet on-time delivery.
Run rough-cut capacity analysis to support workforce planning, work center loading, and bottleneck identification.
Partner with Supply Chain and Purchasing on material availability, and escalate shortages proactively.
Review MRP outputs, reorder reports, and planning tools daily, translating system signals into actionable scheduling decisions.
Maintain and communicate a visible daily production matrix covering work order status, priority changes, and escalation triggers.
Direct production to hit KPIs including on-time delivery, throughput, cycle time, scrap rate, and labor efficiency.
Lead root-cause analysis and corrective action for flow failures, recurring quality escapes, and schedule misses.
Drive continuous improvement using Lean principles: 5S, standard work, visual management, and waste elimination.
Review production data and equipment availability trends, and present operational performance summaries to the General Manager.
Collaborate cross-functionally to resolve product, process, and delivery issues with speed and accountability.
Lead, coach, and develop Production Group Leaders with clear expectations, regular one-on-ones, reviews, and structured feedback.
Own the floor staffing model in partnership with HR: workforce planning, headcount requests, temp-to-perm decisions, and shift structure.
Oversee orientation, on-the-job training, and ongoing skills development, and keep training records compliant with the quality system.
Manage performance concerns, discipline, and employee relations issues with HR, consistent with company policy and California labor law.
Build a culture that treats safety, quality, precision, and continuous improvement as non-negotiable standards.
Ensure all production complies with FDA 21 CFR Part 820, ISO 13485, and applicable SOPs and work instructions.
Maintain cleanroom compliance by enforcing gowning, environmental monitoring response, and contamination-control requirements.
Serve as a production representative in internal and external audits, keeping the floor audit-ready at all times.
Initiate, review, and approve NCRs, deviations, and CAPA records, and verify corrective actions for effectiveness.
Ensure batch records, work order travelers, and production documentation are accurate, on time, and document-control compliant.
Act as an operational point of contact for customer delivery inquiries, status updates, and schedule changes, alongside Customer Service and Program Management.
Build strong customer relationships through proactive communication on production status, shortages, and commitments.
Represent LSO's manufacturing capabilities as the production subject matter expert in customer visits, audits, and business reviews.
Champion a safety-first culture, ensuring required training, proper PPE, and adherence to Cal/OSHA Title 8 and LSO policies.
Conduct regular safety walks and promptly remediate unsafe conditions, near-misses, and non-compliant behaviors.
Partner with EHS and HR to investigate injuries and incidents and track corrective actions to prevent recurrence.