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
Deliverables:
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
Requirements:
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.
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
