The Manufacturing Manager is responsible for overseeing Protein Purification, and Central Services (buffer and equipment preparation) work centers including leading manufacturing floor operations, batch record review, scheduling, personnel training, and containment/escalation of manufacturing issues and deviations.
- Assigns daily duties and tasks to all team members and ensures execution of manufacturing activities in strict accordance with production batch records and standard operating procedures and cGMP.
- Manages and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for performance.
- Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities to Operations management and/or appropriate functional area(s).
- Maintains a safe working environment and reporting incidents/accidents to site leadership.
- Schedules and/or delivers training to manufacturing personnel in accordance with Department Training Plan to ensure staff can perform manufacturing operations correctly, safely and compliantly.
- Partners with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times.
- Promotes “Right First Time” philosophy for all manufacturing activities.
- Operates complex systems and equipment in strict accordance with production batch records, standard operating procedures and cGMP.
- Performs batch record review.
- Supports and adheres to site scheduling processes.
- Demonstrates ability to troubleshoot basic manufacturing process and equipment issues.
- Ensures manufacturing staff identify and document events that deviate from normal operation; supports deviation investigations.
- Partners with Quality Assurance to identify events that are deviations and complete event record.
- Completes investigations, reports, and proposes CAPA for minor deviations.
- Contributes to continual improvement of all manufacturing documentation to ensure they are current, accurate, and clear. Review and refine the current document periodic review process to ensure that all manufacturing documents are accurate and revised as necessary.
- Manages or supports plant floor continuous improvement initiatives.
- High School diploma/GED with 10-15 years of experience in a cGMP environment, Bachelor’s degree with 5-7 years of experience or Master’s degree with 3-5 years’ experience.
- Prior experience with protein purification chromatography
- Prior experience with aseptic cell culture techniques
- 3 years in a lead or supervisory manufacturing role.
- Must have prior experience cGMP manufacturing operations.
- Demonstrated ability to effectively coach and train employees.
- Ability to lift up to 50lbs.
- Process scale-up or process transfer experience.
- Small scale cell culture or fermentation experience.
- Training, coaching, leadership experience.
- Experienced leading manufacturing teams to maintain adherence to a demanding production schedule.
- Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
- Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
- Experienced in managing direct reports.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.