Lead Clinical Development Specialist 2 - Clinical Dev
Posted 1/23/2017 4:02:21 AM
Business Segment: Healthcare Life Sciences
Location(s): India ; Bangalore, Pune, Mumbai, hyderabad, delhi
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: The FastTrak Senior Scientist Position differentiates itself for being in a global group that oversees the global biopharma industry and provides application support in the form of process development, consulting and/or training to the industry and academia. The position is in a highly dynamic group and provides many opportunities for individual career development
Essential Responsibilities: Duties include (but are not limited to):
o Developing expertise for upstream and downstream process development, operation of large scale bioprocess equipment and FDA regulations, understand marketing trends to support sales department and customers with expert advice o Working with customers in a strong collaboration environment o Adding value to GE’s customers by identifying continuous improvement opportunities in their bio-manufacturing processes and designing and implementing innovative process enhancement o Designing, developing and delivering training courses, theoretical as well as practical, in the field of biomanufacturing o To host/train Customers (internal/external) o To maintain accurate and complete records of all work, and report to customer and management in oral and written manner o Conducting independent scientific application work on key projects (Monoclonal Antibodies (MAb's), vaccines, recombinant proteins, plasma fractionation) o Developing and maintaining relationships with the regional commercial and marketing teams, as well as the global Fast Trak and R&D organizations
Qualifications/Requirements: o Master’s/PhD degree in in Basic Sciences, with 4+ years industrial experience in bio-process development, scale-up, tech transfer or manufacturing and analytics.
Desired Characteristics: o MS/PhD Degree in Life Sciences, Chemistry, Physics, Biomedical Engineering, Chemical Engineering or related Life Sciences field o + 4-6 years of Vaccine, MAb plasma, recombinant protein manufacturing and/or process development experience o Strong industrial experience in purification of biomolecules (upstream, downstream (chromatorgraphy, filtration etc), technology transfer, validation, process development, biomanufacturing) o Deep scientific understanding of principles and theory behind unit operations for processing biologicals with knowledge in principles of scale up, validation, disposable, hybrid and traditional set ups and GMP manufacturing for use in training o Industrial Scale Column Packing Experience o Working knowledge of FDA/EMEA regulations for biologics (Phase I-III and manufacturing) o Prior teaching and/or presenting scientific material experience would be highly desirable o Experience with Unicorn™ o Demonstrated ability to work in a collaborative, matrixed, and customer focused environment o Demonstrated ability to establish and maintain relationship with co-workers o Excellent oral and written communication skills o Demonstrated good presentation skills for use internally and for class-room training o Able to operate in a high pace environment with frequent changes and travel as required
Locations: India ; Bangalore, Pune, Mumbai, hyderabad, delhi
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