Production Manager

1 week ago

Andover, Minnesota, United States Ascential Technologies Full time

SUMMARY

The Production Manager is responsible for overseeing the manufacturing operations of pharmaceutical, medical device, and combination products. This role ensures compliance with international cGMP regulations and ISO standards, while driving operational excellence, safety, and continuous improvement across all production processes. This role oversees production teams, budgets, and projects, and drives innovation to enhance manufacturing performance and regulatory alignment.

ESSENTIAL RESPONSIBILITIES

  • Manage daily manufacturing operations, systems, and resources.
  • Ensure production schedules meet demand while maintaining quality and cost targets.
  • Maintain audit-ready state for Regulatory, customer, and internal audits.
  • Ensure compliance with QMS requirements, including CAPA, change control, and documentation.
  • Partner with Quality Assurance to resolve deviations and implement corrective actions.
  • Enforce EHS standards and promote a culture of safety.
  • Lead continuous improvement initiatives using Lean and Six Sigma methodologies.
  • Support technology transfer and process validation for new products and services.
  • Supervise production supervisors, training coordinators, and operators.
  • Manage staffing, training, and performance development.
  • Work with cross-functional teams on new product introductions and lifecycle management.
  • Track KPIs (yield, OEE, scrap, compliance) and report to senior leadership.
  • Prepare and manage operational budgets.

 

EXPECTATIONS

  • Follows applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
  • Perform duties following company quality and safety standards.
  • Participate in team building, training, and department communications.
  • Maintain a high level of personal and professional integrity.
  • Perform additional job responsibilities as assigned.

QUALIFICATIONS

  • Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
  • 7+ years in pharmaceutical, medical device, or combination product manufacturing.
  • Proven leadership in regulated environments (FDA, ISO 13485, cGMP).
  • Knowledge of QMS, process validation, risk management, and documentation control.
  • Familiarity with Class II/III medical device, pharmaceutical, and combination product regulations and requirements.

CORE COMPETENCIES

  • Leadership & team development
  • Operational efficiency & process optimization
  • Regulatory and quality compliance expertise
  • Strong analytical and problem-solving skills
  • Excellent communication and cross-functional collaboration

KEY PERFORMANCE INDICATORS

  • Overall Equipment Effectiveness (OEE)
  • Batch yield and scrap rates
  • On-time delivery performance
  • Deviation closure time
  • Training compliance rate

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