Thermo Fisher Scientific Director Program Design in Boston, Massachusetts
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
The Director, Program Design partners with commercial operations, site leaders, site science leaders and customers to build global scientific strategies that enable delivery of viral vectors and the Viral Vector Services (VVS) business vision. This role requires a rigorous science background, global collaboration and influencing skills, and a customer and solutions mindset.
This position focuses on driving consistency and scientific excellence through the crafting of process development strategy. This strategy helps our clients speed their projects to clinical proof of concept and confirm clinical success while scaling up the drug substance process in readiness to commercialization. This role reports to the Commercial Operations Leader and supports scientific solutions for technical challenges that enable customer satisfaction, Right First Time, and On Time Delivery.
Provide in depth technical knowledge, regulatory consultancy and CMC support with respect to viral vectors, platforms/systems, analytical assays and testing, and cGMP facilities and equipment for manufacturing
Provide technical solutions and options that assist Clients in achieving their viral vector development, production requirements for phase appropriate stage of development to commercial manufacturing across all classes of cell and gene therapies and viral vector types
Work with sales, program management, proposals and marketing teams to support technical expertise in the field and/or marketing initiatives. This includes examining market data trends to identify differentiation in the market and how the PD/AD and manufacturing science team can capitalize on this information.
Build and maintain relationships both internal and external - decision makers
Support new Marketing initiatives by providing expert technical advice as required. Including publications, speaking venues, client visits and thought leadership, understanding and assessing competitive landscape
Evaluate new technology/business segments that require technical input.
Foster a culture that promotes our Core Values as reflected in the Corporation's Code of Business Conduct
Provide technical direction and leadership to staff and sites in connection with current projects to achieve global solutions
Recommend service improvements to site heads, senior management and initiates professional scientific and technical staff discussions and initiates contact with external clients, vendors, and regulatory agencies.
Ensure Unwavering Customer Focus
Drive Functional/Technical & Operational Excellence
Foster Collaboration, Transparency & Team Effectiveness
Inspire & Foster Innovation
Position will require travel both domestically and internationally
Ph.D. required in relevant field (cell/molecular biology, virology) in pharmaceutical / engineering sciences related to pharmaceutical product development
Ten years' experience in biologics development and manufacturing industry
At least three years' experience in viral vector development manufacturing industry
Experience in contract manufacturing industry preferred
Equivalent combinations of education, training, and relevant work experience may be considered.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Subject Matter Expert in techniques used for cell and viral bank generation, cloning and cGMP banking
Subject Matter Expert in DNA molecular, adherent and suspension cell culture, transfection, infection and viral vector harvesting techniques for multiple different cell types, viral vector classes (AAV, AdV, HSV, LV, and RRV), and using all known current manufacturing technologies, strategies and modalities
Subject Matter Expert in viral vector purification techniques including affinity chromatography, ion exchange chromatography, dead-end filtration, tangential flow filtration, sterilizing grade filtration, multiple types of ultracentrifugation for all major viral vector classes
A high-level of expertise in the different small and large-scale development and cGMP equipment and typical equipment parameters used for production of viral vectors (including ambr® 15, bioreactors, filtration equipment, chromatography and TFF skids)
A high level of technical expertise in the areas of viral vector (all types) Drug Product formulation and stability
Subject Matter Expert in the different analytical assay techniques used for different viral vector classes including but not limited to ddPCR, qPCR, ELISA, HPLC, infectivity assays, replication competent cell based assays, analytical ultracentrifugation
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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