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Specialist Manufacturing

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

1. Proficient in Excel, word, and powerpoint. 2. Able to communicate effectively and work with a broad spectrum of departments to produce desired results. 3. Background/experience in downstream biotech operations.

Description:

The Specialist Manufacturing is expected to own and execute SOP and MP revisions according to SOP revamp project. Bin items, Corrective Action and Preventative Action Plans and corrective verification items will also be paramount additions to new SOP format. Responsibilities include, but are not limited to the following:

General:
• Working with peers and floor staff in functional areas for the implementation of best practices, streamlining of operations, and equipment handling into SOPs and MPs
• Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed standard operating practices
• Communication of project status to Senior Leadership in multiple forums (as requested); maintaining the metric reporting for project performance
• Partner cross-functionally across the site to ensure maturity and execution of robust SOPs and alignment opportunities
• Provide timely and comprehensive progress of project scope and status updates to senior management
• Build and present decision point summaries for Senior Management review
• Help to identify and coordinate a team to include all key partners and subject matter experts vital for roll out, and documentation adjustment process
• Lead teams to identify unit op robust documentation strategies and easy ways of getting data to the data lake by effectively utilizing previous biotech experience and working with manager.
Basic Qualifications:
• Doctorate degree, OR
• Master’s degree and 3 years of Manufacturing or Operations experience, OR
• Bachelor’s degree and 5 years of Manufacturing or Operations experience, OR
• Associate’s degree and 10 years of Manufacturing or Operations experience, OR
• High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:
• Scientific degree in Life Sciences or Physical Sciences, Applied Engineering or Manufacturing Technologies
• Biotechnology or Pharmaceutical experience
• Project Management and/or Quality Management skills and experiences
• Experience leading cross-functional/site investigation teams in complex deviations including determination of potential product impact, root cause, and corrective and preventative actions
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction
• Proven leadership traits
• Excellent communication skills, both written and verbal (including technical writing and presentations) with ability to collaborate productively with technical and senior management staff
• Ability to solve complex problems and make scientific risk-based decisions
• Experience presenting to and interacting with representatives of regulatory agencies
• Trackwise database experience
• Direct bulk and fill and finish manufacturing experience
• Aseptic processing knowledge and/or practical experience
Competencies:
• Passion for Operational Excellence
• Communications skills, both oral and written, including presentation skills
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met
• Ability to tactfully negotiate and positively influence peers and executive leadership
• Analytical skills to identify potential improvement opportunities

"This posting is for Contingent Worker, not an FTE"
 

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