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Job Location drjobs

Lexington, KY - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Our Work Matters

At Kindeva we make products that save lives ensuring better health and wellbeing for patients around the world.

Why Kindeva

  • Purposedriven work environment
  • Significant growth potential
  • Collaborative team culture
  • Direct impact on patient care
  • Industryleading innovation

At Kindeva Lexington KY were not just making products were manufacturing lifesaving nasal spray medications that make a difference.

The Impact You Will Make:

Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. The Manufacturing Manager will oversee the maintenance operations within our Kindeva Lexington facilities. This is a handson role that will lead shift for both commercial and development manufacturing campaigns ensuring adherence to CGMP standards and regulations.

The manager will be responsible for staff training and development driving key performance indicators (KPIs) and leading change/improvement initiatives within the department.

Responsibilities:

Leadership and Management:

  • Plan and manage commercial and development manufacturing campaigns coordinating with crossfunctional teams to ensure timely and successful product delivery.
  • Manage resource allocation including personnel equipment and materials to meet production schedules and goals.
  • Lead mentor and develop a team of manufacturing professionals fostering a culture of continuous improvement and high performance.
  • Drive the manufacturing department to meet or exceed performance KPIs including productivity quality and safety metrics.
  • Implement and manage change initiatives to improve manufacturing processes and efficiencies.

Compliance and Quality Assurance:

  • Ensure all manufacturing processes and outputs meet the strict quality standards required for pharmaceutical products and medical devices.
  • Maintain compliance with CGMP FDA and other relevant regulatory bodies by enforcing proper documentation procedures and audit readiness.
  • Conduct regular facility assessments and participate in internal and external audits addressing any findings promptly.
  • Ensure the proper maintenance and calibration of manufacturing equipment and facilities to support uninterrupted operations.
  • Change Management:
  • Lead and manage change management efforts within the department including process improvements system upgrades and organizational changes.
  • Communicate effectively with stakeholders at all levels to ensure smooth transitions and minimize disruption to operations.
  • Monitor and assess the impact of changes on manufacturing performance.

Qualifications:

  • Bachelors degree in Engineering Science or related technical field. Advanced degree preferred.
  • Minimum 10 years of experience in pharmaceutical manufacturing with a focus on CGMP environments.
  • Minimum 3 years in a management role with responsibilities for a multishift pharmaceutical operation
  • Proven leadership experience including staff management training and development.
  • Strong understanding of CGMP regulations FDA requirements and other relevant industry standards.
  • Experience managing both commercial and development manufacturing campaigns.
  • Demonstrated success in driving performance through KPIs and continuous improvement initiatives.
  • Strong problemsolving decisionmaking and change management skills.
  • Excellent communication and interpersonal skills.

Preferred:

  • Experience with medical device manufacturing.
  • Certification in Lean Six Sigma or related continuous improvement methodologies.
  • Proficiency with manufacturing software and systems (e.g. ERP MES SCADA OSI PI).

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and wellbeing for patients worldwide.

# LIOnsite


Required Experience:

Manager

Employment Type

Full-Time

Company Industry

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