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Km80.5

Sr Supervisor, Fermentation Manufacturing

Novartis Vaccines & Diagnostics, Inc.

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Location: Emeryville, CA Posted Date: 4/24/2013 Position Type: Full time Job Code: 3506626HHL Salary: Competitive Required Education: Bachelors Degree Areas of Expertise Desired: Allied Health

Description


This position will be responsible for supervising the activities associated with the Fermentation area. Lead and oversee all - functional activities associated with antigen fermentation production in a multi product GMP facility. Collaborate with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, Technology Development, Engineering, and Validation to accomplish organizational objectives. Supervise the activities of production operators to ensure safe and compliant production of commercial antigens. Responsible for all regulatory compliance activities and assures group compliance to cGMP and regulatory requirements through monitoring, trending, and auditing. Ensure safety and compliance regulations are enforced. Follow valid manufacturing procedures and documentation. Ensure batch records, logbooks, inventory forms, in-process data spreadsheets, and associated attachments are completed in a timely manner and accurately. Ensure applicable Change Control policies and procedures are followed for new or modifications to existing facility, equipment, processes. Investigate assigned deviations in a timely manner to identify root causes of problems and implement appropriate corrective actions to prevent from reoccurrence. Ensure timely completion of assigned Corrective and Preventative Actions (CAPAs) Analyze antigen production processes and environment to identify opportunities for continuous improvement and develop a culture of operational excellence. Develop and draft new Fermentation Standard Operating Procedures (SOPs), modify or eliminate outdated/ineffective SOPs when appropriate. Be a liaison to other Technical Operations and Quality groups promoting cross collaboration for organizational projects. Ensure appropriate planning for successful execution of production activities Ensure SAP transactions are being performed per agreed timeframes for different stages in the manufacturing process.
BA/BS degree in chemistry, biology, or related field. Fluent in English Minimum of 8+ years of GMP experience including 3+ years of supervisory or team leadership experience Must have in-depth knowledge of commercial fermentation Must have a thorough understanding of cGMPs. Must be creative, highly organized, self-motivated, perceptive, and innovative. Must have strong written and verbal communication skills. Must be able to manage a diverse group of people with different strengths and skills. Must have highly developed individual as well as team performance management skills. Must be able to handle multiple priorities and delegate responsibilities while maintaining quality. Must have excellent team building and project management skills Must have direct experience with Lean, 5S, and Operational Excellence. Must have experience with SAP including cycle counting and inventory reconciliation. Must have experience drafting and revising SOPs as well as batch records. Must be proficient using MS Outlook, Word, Excel, and PowerPoint.

Requirements

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