Manager, External Supply (Cell & Gene Therapy)
King of Prussia , Pennsylvania
February 21, 2017
Basic qualifications:
• Broad knowledge of CGT or biological manufacturing. Qualified to at least graduate level in Biochemistry, Biotechnology and/or (Bio)Chemical Engineering with a minimum of 5 years experience in a CMC development and/or manufacturing environment, or qualified to Bachelors level with 10+ years experience a CMC development and/or manufacturing environment.
• Strong interpersonal and leadership skills. Solid team player able to function within a matrix team environment. Capable of working independently with minimal direct supervision.
• Excellent troubleshooting/problem analysis skills. Familiarity with Lean Sigma and Root Cause Analysis methodologies highly desirable.
• Effective time and energy management with an ability to clearly identify priorities and manage multiple tasks while working in a matrix team environment.
• Ability to manage a dynamic project workload and evolving CMC priorities suitably balancing demands of individual assets vs. the needs of the overall CGT portfolio.
• Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise.
• Has direct experience managing activities and/or services provided by external suppliers/contractors and has experience supporting negotiation of timelines, costs, and deliverables for such work packages.
• Has experience in "identifying outsourcing opportunities and presenting business cases to key internal partners"
• May be required to provide direct oversight of development/ cGMP activities and may support due diligence activities with some travel required.
• Maintains awareness of scientific literature and new technologies in their technical discipline which have relevance for CGT.

Preferred qualifications:
• Knowledge of external supplier capabilities/organizations (philosophy, culture, business goals) and how they relate to GSK.
• Experience developing innovative, simple and cost effective alternatives for delivering CMC activities of suitable/ phase appropriate quality.

Key responsibilities include, but are not limited to the following:
• Capably leads joint teams with external parties tasked with manufacture and testing/release of CGT products or critical inputs (e.g. plasmids, cell banks, viral vector).
• Effectively communicates across extended matrix teams comprising CGT, QA, Program/ Project Teams/ GSK Procurement organizations, and external supplier organizations.
• Proactively defines and implements CGT CMC and sourcing plans, critically evaluating these against business requirements to ensure project objectives are met. Develops contingency plans and proposes alternative strategies as appropriate.
• Initiates and implements continuous improvements in ways of working.
• Develops relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct.
• Actively involved in on-boarding and on-going management of external parties. Effectively integrates external partners into the project structure and educates suppliers on the mechanics of doing business with GSK.
• Significant external influencing required ensuring alignment of GSK business requirements with supplier's expectations. Ensures protection of GSK IP in all Supplier interactions.
• Manages and delivers against all project objectives as per agreed Scope of Work (scope, time, budget, resources and quality).
• Participates in performance reviews of preferred suppliers. Coordinates, manages & reports Key Performance Indicators (Performance measures) on a regular basis.
• Must have experience ensuring adherence to regulatory guidelines and corporate policies as they relate to outsourcing of development and manufacturing activities for CGT or biopharms.
• Responsible for monitoring the integrity and quality of partner derived data ensuring it is suitable to support robust manufacturing/ testing and associated GSK regulatory filings.
• Contributes to global outsourcing policies and third party oversight for CGT / R&D.

Contact information:

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