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Director of Operations - (US-CO-Boulder - 80329)
Minimum Education: Tech School Job Type: Full Time Email this job to yourself or to a friend | Job Match Test | Resume Guide
Click Here to Apply OnlineMerck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.
Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Position Summary: Provide leadership and direction to department in support of various product development programs while maintaining adherence to cGMP regulations.
In this position you will have the opportunity to:
Direct cGMP Therapeutic Protein plant operations to comply with business drivers and cGMP requirements.
Ensure optimum performance of the Operations department by determining and implementing techniques to improve productivity manage costs and maintain state-of-the-art practices.
Review manufacturing quality control and operational data to determine root causes of nonconformity with specifications and/or operating deviations.
Participate on cross-functional teams throughout the product lifecycle in order to support relevant cGMP development requirements successfully meet production goals and manage required change controls.
Work closely with the quality assurance department to perform audits and ensure timely review and release of batch records.
Manage performance of direct reports by providing coaching and counseling and identifying training and development needs.
THIS POSITION WILL REPORT TO:
DAVID MITCHELL EXECUTIVE DIRECTOR MBV MANUFACTURING
EDUCATION REQUIREMENT
A BS/BA degree in life sciences physical sciences engineering or equivalent required.
REQUIRED EXPERIENCEEight plus years of bio/pharmaceutical experience including a minimum of five years management experience required.Significant functional group management experience in a cGMP manufacturing environment including familiarity with bioprocesses and aseptic manufacturing.Experience defining problems collecting data establishing facts and drawing valid conclusions.Experience transferring technology/processes into manufacturing.In-depth knowledge of all manufacturing activities and regulatory requirements in the pharmaceutical/medical industry.Strong working knowledge of cGMPs and an ability to interpret and enforce regulatory requirements.Ability to communicate professionally knowledgably and efficiently with a wide range of employees and with all internal and external customers both in writing and verbally.Strong collaborative bent and teamwork orientation.Demonstrated organizational and communication skills and strong interpersonal effectiveness.Ability to define problems collect data establish facts and draw valid conclusions
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