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Job #03355

About our client Our client is a small privately owned company that develops and manufactures a diagnostic product. Position Location Manufacturing Manager West Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development, implementation and ongoing support of manufacturing business systems including clinical and commercial production activities 2) Ensure plans and resources (people, facilities, supplies, etc.) are efficiently utilized to ensure uninterrupted supply of products produced 3) Oversee the production operations associated with the manufacture of all GMP products 4) Develop comprehensive operating plans/budgets and monitor achievement of business as well as financial goals 5) Oversee hiring, development, retention and optimal performance of staff for the leadership and execution of manufacturing operations 6) Develop weekly/monthly goals and schedules for supervisors 7) Manage activities through shift or unit supervisors 8) Oversee progress of supervisors’ daily schedules to ensure safe and timely completion of releasable products 9) Act as the primary person for technical and compliance issues 10) Liaise with internal groups (QA, QC, Regulatory, etc.) to facilitate issue resolution 11) Ensure functional units comply with GMP and all its related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records 12) Negotiate process manufacturing agreements (if needed) or manage external manufacturing contracts 13) Interact effectively with outside vendors and departments 14) Schedule validation activities and train operators 15) Write/approve maintenance work requests, engineering and facility change requests as well as purchase requisitions Requirements 1) BS in a relevant Science or Engineering discipline 2) Minimum 5 – 8 years of experience in a biotechnology manufacturing/quality/development environment, preferably with IVD devices 3) Thorough knowledge and understanding of cGMPs and familiarity with FDA, ISO and CE guidelines