Human BioSciences, Inc. USA
Production Manager Assistant
Human BioSciences, Inc. USA, Martinsburg, West Virginia, us, 25402
Position Overview
The Production Head is responsible for the safe, efficient, and compliant operation of manufacturing activities within a biomedical production facility. This role provides strategic leadership and daily hands‑on oversight to ensure products are manufactured to required specifications, comply with regulatory standards, and are delivered on schedule. The Production Head will oversee production planning, ERP and inventory control, material resource planning, and cross‑functional communication to drive operational excellence in a GMP environment.
Location:
Martinsburg, West Virginia, USA
Start:
Immediate start preferred
Key Responsibilities Operational Leadership
Lead and manage daily manufacturing operations across multiple cleanroom or controlled production lines.
Develop and execute production plans and schedules to meet output, cost, and delivery targets.
Drive workforce planning, staffing, and development to ensure adequate skill coverage and productivity.
Coordinate with Engineering, Supply Chain, R&D, and Quality for process transfers, changes, and technical support.
Quality & Compliance
Ensure operations align with GMP/GDocP, ISO 13485, FDA/EMA, OSHA, and biomedical manufacturing regulations.
Oversee accurate completion of batch records, controlled SOPs, change controls, and validation activities.
Support internal and external audits and resolve compliance deviations through CAPA processes.
ERP, Inventory & Material Resource Planning
Serve as the production department owner and primary user of the ERP/MES system; ensure proper transactional integrity and data accuracy.
Direct plant‑wide material resource planning (MRP) to ensure materials, consumables, and components meet production demand.
Work with Supply Chain and Purchasing to monitor lead times, manage safety stock levels, and prevent material shortages or overstocking.
Maintain material traceability, lot control, and expiry management within the ERP.
Review and approve inventory cycle counts and inventory accuracy reports.
Identify ERP system improvement opportunities and support implementation of new modules or functionality.
Process Management & Efficiency
Establish and monitor KPIs (throughput, efficiency, downtime, scrap, OEE, labor utilization).
Lead Lean, Six Sigma, and continuous improvement initiatives to reduce costs and improve productivity.
Oversee preventive maintenance coordination and ensure equipment readiness and uptime.
People Management
Recruit, coach, and retain production staff; manage training programs for cleanroom, sterile handling, and equipment skills.
Enforce shift discipline, resolve operational conflicts, and conduct performance reviews.
Support organizational culture through communication, accountability, and developmental leadership.
Safety & Facility Control
Implement and maintain strict EHS policies and hazard controls.
Ensure safe machine operation, chemical handling, and waste disposal.
Promote a safety‑focused culture with zero‑tolerance for unsafe practices.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Administrative
#J-18808-Ljbffr
Location:
Martinsburg, West Virginia, USA
Start:
Immediate start preferred
Key Responsibilities Operational Leadership
Lead and manage daily manufacturing operations across multiple cleanroom or controlled production lines.
Develop and execute production plans and schedules to meet output, cost, and delivery targets.
Drive workforce planning, staffing, and development to ensure adequate skill coverage and productivity.
Coordinate with Engineering, Supply Chain, R&D, and Quality for process transfers, changes, and technical support.
Quality & Compliance
Ensure operations align with GMP/GDocP, ISO 13485, FDA/EMA, OSHA, and biomedical manufacturing regulations.
Oversee accurate completion of batch records, controlled SOPs, change controls, and validation activities.
Support internal and external audits and resolve compliance deviations through CAPA processes.
ERP, Inventory & Material Resource Planning
Serve as the production department owner and primary user of the ERP/MES system; ensure proper transactional integrity and data accuracy.
Direct plant‑wide material resource planning (MRP) to ensure materials, consumables, and components meet production demand.
Work with Supply Chain and Purchasing to monitor lead times, manage safety stock levels, and prevent material shortages or overstocking.
Maintain material traceability, lot control, and expiry management within the ERP.
Review and approve inventory cycle counts and inventory accuracy reports.
Identify ERP system improvement opportunities and support implementation of new modules or functionality.
Process Management & Efficiency
Establish and monitor KPIs (throughput, efficiency, downtime, scrap, OEE, labor utilization).
Lead Lean, Six Sigma, and continuous improvement initiatives to reduce costs and improve productivity.
Oversee preventive maintenance coordination and ensure equipment readiness and uptime.
People Management
Recruit, coach, and retain production staff; manage training programs for cleanroom, sterile handling, and equipment skills.
Enforce shift discipline, resolve operational conflicts, and conduct performance reviews.
Support organizational culture through communication, accountability, and developmental leadership.
Safety & Facility Control
Implement and maintain strict EHS policies and hazard controls.
Ensure safe machine operation, chemical handling, and waste disposal.
Promote a safety‑focused culture with zero‑tolerance for unsafe practices.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Administrative
#J-18808-Ljbffr