Director of Manufacturing

manufacturing, production manager, medical manufacturing, manager, medical equipment
DIRECTOR OF MANUFACTURING
Stedim Biosystems, a pioneer and world leader in sterile bag technology systems for the biopharmaceutical industry, is seeking a highly motivated, hands on, team player to join our Operations Department at our North American Manufacturing Facility in Concord, CA. Stedim Biosystems’ customers include the leading Biotech, Pharmaceutical and Animal Health companies of the world.

Position Summary: This position directs and oversees all manufacturing and related functions for the production process of disposable bio-process containers in a cGMP and ISO9002 manufacturing environment.

Duties:Ensure product quality standards expected by Biotech industry are exceeded.Work directly with the Director of Quality to generate metrics, analyze root cause of non-conformances and implement corrective actions. Must embrace and execute production based on the belief that manufacturing is ultimately responsible for produce qualityEnsure a highly motivated and well trained staff is available to meet the lead time demands of the Biotech industry, while maintaining budgeted labor costs. Must be adept at managing simultaneous production of varying lot size and custom assemblies. Ensure all documentation, procedural, and safety requirements as prescribed by cGMP and the Biotech industry are instituted and executed without exception. Maintain goal of zero customer audit findings. Represents manufacturing in customer audits and business meetings as necessary. Manage maintenance function to ensure all equipment is properly calibrated and operating at maximum efficiency and safety. Interface with process engineering to prioritize projects, introduce new technologies and methods, and to improve ergonomics. Develop capital/expense budgets and ensure financial and operating targets are met. REQUIREMENTS
Job Requirements, Director of Manufacturing:
Education: BS Degree
Experience:10 + years of progressive manufacturing management experience. Strong understanding of cGMP principles. Plastic sealing and assembly preferred. Experience in medical device manufacturing preferred. Knowledge of JIT production and bar coding a plus. Experience in cleanroom production a plus.
Other Requirements:Excellent communication, organizational, and interpersonal skills Stedim Biosystems offers a competitive compensation plan including full benefits, 401k, and a performance based bonus program in a challenging and rewarding setting. If you believe that you would like to be considered for the position and become the newest member of the Stedim Biosystems team, please submit your resume with salary requirements in complete confidence to:
Stedim Biosystems
1910 Mark Court
Concord, CA 94520
Attn: DOM-001
Or email:
[Click here for email]
Stedim Biosystems is an equal opportunity employer.

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