Manufacturing Manager - #246651

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Why Kindeva?

• Purpose-driven work environment
• Significant growth potential
• Collaborative team culture
• Direct impact on patient care
• Industry-leading innovation
  
  

At Kindeva – Lexington, KY, we're not just making products – we're manufacturing life-saving 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 hands-on role that will lead shift execution 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 cross-functional 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.
  
  

Required

Qualifications:

• Bachelor’s 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 multi-shift 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 problem-solving, decision-making, 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 well-being for patients worldwide.

# LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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