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US: Sr. Bioprocess Engineer

Date: 19-Mar-2015
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Sr. Bioprocess Engineer

Responsibilities will include:

Leading the technical input and direction on Production Planning and Materials Management, Quality issues (Deviation Management, Product Release, Change Control), Technology issues (Technology transfers, Investigations, Process Improvements, etc.), Operational Excellence and Continuous Improvement activities Interfacing on a regular basis with Supply Chain Management team to establish priorities and execute both near and long term supply and capacity plans Collaborating with manufacturing leadership on contract negotiations (initiation and renewal), Business Review Meetings, signification dispute resolution and management of Key Performance Indicators with suppliers and external partners Working in partnership with quality operations management (e.g. product release, quality assurance compliance, batch release, deviation management, etc.) and direction on all applicable policies, guidelines and systems for the achievement of GMP compliance


Build the future Manufacturing support for biologics for all GIGS Execute excellence in meeting all Manufacturing and operations milestones while building an innovative approach to operations Lead Manufacturing with ability to mobilize a broader team Execute strategic direction for biologics manufacturing Influence change through data-driven analysis and facts delivered in business case presentation Ability to manage by influence in environment without direct authority, e.g. with CMOs Team player who is goal oriented and able to adapt to changing scopes and still deliver Establish successful strategic partnerships established with suppliers and CMOs who perform outstandingly and add real value to the supply chain Manufacturing and Supply managed according to global requirements set by supply chain planning Provide technical evaluation of bioprocess technologies for application to MDCO products Achieve excellent Customer Service levels achieved and all deliveries on-time according to customer need. Influence external manufacturers in a complex environment and achieving results required to achieve MDCO financial and supply targets Make certain MDCO’s cost of goods targets are achieved Ensure line item annual budgets achieved Oversee bulk protein processes used in the manufacture of MDCO products Provide leadership in the evaluation of new bioprocess technologies Support New Business Ventures in the evaluation of biological products Advocate of MDCO values, beliefs, language, structure and processes


10 years experience in commercial recombinant protein manufacturing Bachelor’s degree in Biological Science or Engineering MS or MBA desired but not required Biologics manufacturing experience/expertise in a direct manufacturing (plant environment) or in contract manufacturing Experience in managing CMOs preferred Proven skills running process development and/or operations for cell culture, fermentation, recovery, and utrafiltration and chromatography purification Expertise in either fermentation or purification processes Knowledge of cGMP and experience of working with Supply Chain, Quality, Regulatory and Technical Operations is necessary Have the ability to use independent judgment and creativity to resolve issues. Excellent management and communication skills Exceptional customer service mentality Ability to work within multi-national matrix environment organization.

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