Manufacturing Lead
Takeda
Full-time
On-site
Social Circle, GA
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Manufacturing Lead responsible for executing all production processes in compliance with cGMP, EHS guidelines, and applicable regulations. Manages hands-on activities in the production area, acts as a delegate to the supervisor, and leads transfer of new processes/methodologies into manufacturing. May participate in departmental projects and quality teams.
Responsibilities
- Support all local manufacturing operations.
- Assist the supervisor in organizing, scheduling, and directing other team members.
- Conduct shift change meetings in lieu of the 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.
- 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.
- Assist 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 associate's degree or higher with 4+ years related work experience.
Skills
- Hands-on production leadership
- Process troubleshooting and problem solving
- Documentation and GDP/GMP compliance
- Continuous Improvement and project coordination
- Communication and cross-functional collaboration
Education
- High school diploma or GED; additional associate's degree or higher preferred.
Additional Requirements
- Work in controlled environments with gowning and protective clothing; may require respiratory protection in areas with chemicals.
- Work in cold, wet environments; may require weekend and shift work.