Manufacturing Lead

Role Summary

As a Manufacturing Lead, you will execute all production processes while strictly following cGMP, environmental health and safety guidelines, and other applicable regulations. You will participate in departmental projects and quality teams, manage hands-on production activities under the supervisor's direction, and may conduct departmental activities in the supervisor's absence. You understand the regulations and may make recommendations according to their interpretations. You will be responsible for the successful transfer of new processes and methodologies into the manufacturing area.

Responsibilities

• Support all local manufacturing operations.
• Assist supervisor in organizing, scheduling and directing other team members.
• Conduct shift change meeting in lieu of shift supervisor.
• Troubleshoot process problems and respond to process alarms. Main troubleshooting/response person.
• Operate general production equipment for the assigned area.
• Prepare media and buffer solutions.
• Main 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.

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.