Manufacturing Lead

Role Summary

Manufacturing Lead - As a Manufacturing Lead, you will execute all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You are expected to participate in both departmental projects and any quality working teams which may be applicable. Under the overall direction of the supervisor, this position shall manage the hands-on execution of all activities in the production area. In addition to being accountable and involved in all production processes, you will act as a delegate to the supervisor and may conduct departmental activities in their absence. You understand the regulations and may make recommendations according to their interpretations. You will be responsible for the successful transfer of new processes/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.

Skills

• Strong understanding of cGMP, environmental health and safety guidelines, and related regulations.
• Proficiency in operating production equipment and preparing media/buffer solutions.
• Problem-solving and troubleshooting; ability to respond to process alarms.
• Documentation and data analysis capabilities; ability to write, revise and review documentation.
• Leadership and team coordination; ability to train others and lead process improvement initiatives.

Education

• High school diploma or GED; or an associate degree or higher with relevant experience.

Additional Requirements

• Work in controlled environment with gowning and protective clothing; possible hearing protection.
• May require removal of makeup/jewelry etc. while in manufacturing environment.
• Work in cold, wet environment; may require work on multiple shifts including weekends.
• Work around chemicals requiring respiratory protection.