Production Technician, Lead

Kindeva Drug Delivery Company; Lexington (KY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in drug delivery is seeking a Manufacturing Team Leader for its Lexington facility. The individual will oversee production operations, ensuring compliance with GMP standards while developing and coaching production staff. This role offers an opportunity to drive efficiency and quality in vital manufacturing processes that deliver life-saving treatments.

Qualifications

• Minimum of 2+ years of experience in a GMP manufacturing environment.
• Demonstrated ability to lead or coordinate teams in a production setting.
• Familiarity with SOPs and pharmaceutical production processes.

Responsibilities

• Lead daily production operations and ensure adherence to GMP standards.
• Monitor key performance indicators (KPIs) and provide direction to production technicians.
• Support training and development of staff, maintaining current training records.

Skills

Leadership

GMP Compliance

Effective Communication

Organizational Skills

Job description

Manufacturing Team Leader (Lexington Site)

Our Work Matters

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

As a Manufacturing Team Leader at our Lexington facility, you will play a vital role in leading daily production operations, ensuring adherence to Good Manufacturing Practices (GMP), and driving efficiency and quality across a designated production area. You will directly support and develop production technicians, oversee compliance and training, and help deliver life-saving treatments to patients by ensuring excellence in every aspect of manufacturing execution.

Responsibilities:

Production Oversight and Team Leadership

• Lead daily production operations for a specific manufacturing area, ensuring production goals are met and staff are working efficiently and safely.
• Monitor and report key performance indicators (KPIs) such as output, quality, and efficiency.
• Provide direction and support to production technicians, ensuring compliance with SOPs and quality standards.
• Conduct daily team briefings to communicate production targets, policy updates, and shift objectives.
• Partner with supervisors to address performance or compliance issues in real time.

GMP Compliance and Documentation

• Ensure all tasks are executed in accordance with GMP standards.
• Review completed batch records and other documentation to confirm accuracy and compliance with Good Documentation Practices (GDP).
• Oversee adherence to cGMP practices during operations and escalate deviations when necessary.

Staff Training and Development

• Ensure all staff are trained on equipment, procedures, and GMP requirements.
• Maintain current training records and provide ongoing coaching to enhance team capability.
• Support onboarding and cross-training to build a flexible, capable workforce.

Schedule and Shift Coordination

• Monitor and manage staff break schedules to ensure compliance with internal policies and external regulations.
• Coordinate effectively with other Team Leaders and departments to enable smooth shift transitions and area alignment.
• Identify and act on opportunities to improve manufacturing processes, reduce waste, and increase efficiency.
• Collaborate with cross-functional teams to implement lean manufacturing and continuous improvement initiatives.

Basic Qualifications:

• Minimum of 2+ years of experience in a GMP manufacturing environment.
• Demonstrated ability to lead or coordinate teams in a production setting.
• Familiarity with SOPs, batch record documentation, and pharmaceutical production processes.
• Strong knowledge of GMP compliance and FDA-regulated environments.
• Effective communicator with strong organizational, interpersonal, and leadership skills.
• Ability to make sound decisions with moderate supervision and work collaboratively in team-based environments.

Preferred Qualifications:

• Experience in lean manufacturing or continuous improvement programs.
• Prior experience leading teams in a regulated manufacturing setting.

Physical Requirements:

• Must be able to read, comprehend, and follow documentation related to GMP and safety procedures.
• May be required to lift or move up to 20 pounds.
• Must follow all GMP and safety procedures in the department.
• Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus.

#LI-Onsite

Job Family D - Production Operations - Production Operations