Director of Manufacturing Job at Tiger BioSciences LLC, Franklin, WI

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  • Tiger BioSciences LLC
  • Franklin, WI

Job Description

Purpose

The Director of Manufacturing is responsible for overseeing all manufacturing staff and all manufacturing activities to ensure continuity of production to support organizational goals.

Responsibilities

  • Direct and oversee the manufacture of medical devices – including implantable devices – ensuring production, performance, and quality standards are consistently met in accordance with established procedures and aligned with organizational strategy and goals
  • Provide after-hours or on-call support remotely or on-site as needed for production, environmental monitoring alarms, personnel issues, and/or emergency events
  • Oversee management of production schedules to support distribution and sales forecasts
  • Establish production metrics and provide routine reporting to executive management
  • Plan, direct, and coordinate Lean Six Sigma process improvement initiatives
  • Organize and maintain department structure and teams for optimal, efficient operations
  • Support the development of management structures for operational support departments
  • Direct and oversee department training programs for new employee onboarding
  • Support executive management with long-term operating goals, expansion efforts, and the implementation of new technology
  • Drive department accountability for quality and efficiency
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, ISO 13485 and other regulations (as appropriate), and industry standards
  • Review and approve reimbursement requests for operational staff
  • Author, revise, and maintain procedures in compliance with FDA, AATB, and other applicable regulations
  • Oversee management of equipment qualification plan development
  • Review and approve equipment and process validation/verification/qualification protocols, execution data, and summary reports in compliance with FDA, AATB, and other applicable regulations
  • Collaborate with Product Development/Management to establish and support project timelines
  • Plan, direct, and drive implementation of new production processes in collaboration with Product Development, Quality Assurance, and Regulatory Affairs
  • Integrate shared leadership and foster collaboration across multi-disciplinary teams
  • File and maintain records in accordance with standard operating procedures
  • Support internal and external audits
  • Develop and maintain relationships with key stakeholders, including vendors, customers, and employees
  • Participate in proposal presentations and face-to-face interactions with clients and customers
  • Develop and implement the department budget
  • Manage direct reports, including establishing and monitoring objective annual goals, providing feedback, and conducting performance reviews
  • Recruit, interview, and select personnel for hire
  • Travel domestically up to 15% to attend offsite meetings, conferences, and support business initiatives
  • Maintain acceptable attendance and punctuality for scheduled work hours and meetings
  • Ensure completion of assigned tasks and responsibilities within defined timeframes
  • Flexibility to work outside normal business hours during weekdays or weekends with reasonable advance notice to support operational needs
  • Perform other duties as assigned

Skills

  • Strong communication skills, with the ability to communicate effectively with stakeholders at all levels
  • Excellent interpersonal and negotiation skills
  • Strong leadership and management skills, with the ability to inspire and motivate teams
  • Excellent analytical and problem-solving skills, with the ability to identify opportunities for improvement and implement solutions Ability to work in a fast-paced environment and manage multiple priorities
  • Ability to secure and maintain a favorable background investigation and clearance

Qualifications/Requirements

  • Bachelor’s degree in life sciences, finance, operations management, or business, or a related field, from an accredited college or university required
  • Master’s degree in life sciences, finance, operations management, or business, from an accredited college or university preferred
  • At least 10 years of experience in operational management, quality assurance, finance, or relevant cross functional role required
  • At least 5+ years of experience in Medical Device Manufacturing Management preferred
  • Experience working in environments compliant with cGMP and MDSAP standards preferred
  • Clearance of favorable background investigation required

Job Tags

Remote job, Weekend work, Weekday work,

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