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POST :: Director of Biologics Manufacturing

Job Date :: 6/2/2015
Division :: MANUFACTURING/OPERATIONS
Job Location :: Vancouver, BC
Qualification :: Desired
Salary :: Negotiable
Experience :: 15+
Details ::

Responsible for establishing cost-, quality- and compliance-driven visions and strategies for commercial manufacturing of biologics. Establishes and oversees global biologics commercial manufacturing supply chains under cGMP for biologics drug substances. Manage life-cycle of pharmaceutical biologics drug substance manufacturing from late stage development to commercialization. Implements phase-appropriate CMC and manufacturing strategies for the biologics. Works collaboratively with senior leaders in Process R&D, Quality, Drug Product (sterile drug product fill/finish production), Analytical, Regulatory, Finance, Facility, Clinical and Legal departments to ensure delivery of commercial product is achieved meeting the Champions continuous improvement, new ideas, and initiatives that drive the business forward. Knowledge, experience and skills 5+ years of relevant experience in the biopharmaceutical industry with a BS or MS degree in biochemistry or chemical engineering, or another relevant scientific discipline A MBA/Ph.D. degree a plus Excellent business and technical acumen in the field of biological drug substance manufacturing, excels in developing, negotiating and administrating commercial supply, quality, and manufacturing agreements. Extensive experience of successfully managing contract manufacturing and research organizations. In-depth understanding of cGMP manufacturing of clinical and commercial biopharmaceutical proteins Knowledge and sound track record of life-cycle management for biopharmaceutical manufacturing Ability to establish and manage strong and effective relationships with external contractors Ability to create strong and clear visions and implement those effectively in his functional area Ability to create an exceptional working environment for his/her team Ability to lead global cross-functional teams including external contractors to achieve milestones, responsible for overseeing the operations at internal and external