Manufacturing Lead

Role Summary

Manufacturing Lead responsible for executing production processes in compliance with cGMP and relevant safety guidelines. Manages hands-on activities in the production area, delegates tasks in the supervisor’s absence, and supports transfer of new processes into manufacturing.

Responsibilities

• Support all local manufacturing operations.
• Assist supervisor in organizing, scheduling and directing other team members.
• Conduct shift change meetings in lieu of shift supervisor.
• Troubleshoot process problems and respond to process alarms as the main troubleshooting/response person.
• Operate general production equipment for the assigned area.
• Prepare media and buffer solutions.
• Interface with other departments to resolve issues related to equipment, process, and compliance, including maintenance, metrology, and validation.
• Complete relevant paperwork following GDP/GMP guidelines.
• Write, revise and review important documentation.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Represent the department in teams.
• Initiate and coordinate other process improvement projects.
• Train other team members.
• Help with process/equipment validation and data analysis.
• Assign other project work and/or involvement in teams to team members.
• Perform removal of hazardous waste.

Qualifications

• Requires high school diploma or GED plus 6+ years of experience or associates' degree or higher with 4+ years related work experience.

Requirements / Skills

• Understanding of cGMP, environmental health and safety guidelines, and related regulations.
• Ability to follow and interpret regulations and make recommendations accordingly.
• Experience with documentation management and GDP/GMP guidelines.
• Strong problem-solving, teamwork, and communication skills.
• Ability to work in a controlled environment, including gowning and protective clothing.

Education

• High school diploma or GED; associate degree or higher preferred with related experience.

Additional Requirements

• Ability to work in cold, wet environments and around chemicals requiring respiratory protection.
• Ability to work multiple shifts, including weekends, or supplemental hours as needed.