Supervisor, Downstream Purification

BioSpace · Novato, CA · 2 mo ago

ManagementFull-time

Leads the daily operations in the area, making appropriate decisions, troubleshooting, and ensuring schedules are adhered to with minimal oversight
Directs and provides hands-on training to staff members
Manages staff effectively, setting standards and fostering a culture of compliance, strong work ethic, and continuous learning
Takes responsibility for complex projects and interacts effectively with peers across manufacturing to achieve alignment and improvements
Pairs with support groups such as Facilities, Validation, MSAT, and Quality to complete scheduled activities

Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
Able to troubleshoot, identify issues, and support resolutions with technical groups
Performs ongoing operational tasks in respective work area using scientific thinking and decision-making

Comprehensive understanding and adherence to cGMPs as related to commercial operations
Initiates and owns required Corrective and Preventative Actions and leads change control actions
Supports the closure of manufacturing discrepancies and change requests
Current understanding of FDA and EMEA guidelines, cGMPs for Manufactured Drug Products

Experience with business systems such as Process Historian, LIMS, Trackwise, ERP, MES
Supports trend analysis and communication of departmental metrics
Identifies and drives opportunities for process and business optimization
Translates company and department goals into actionable objectives for self and staff

Bachelor’s degree in Life Sciences, Engineering, Applied Physics, or an acceptable equivalent combination of education and experience
At least 4 years of directly related industry experience, including at least 2 years with proven leadership roles

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