Sustains high level of innovative and independent research as appropriate.
Leads and manages projects within the functional area.
Serves as a subject matter expert for cryogenics and transportation processes of commercial and late stage biologics drug substance across the global network and contract storage/manufacturing sites.
Designs, prepares and reviews required CMC documentation as appropriate.
Identifies, executes and leads process/system improvement projects.
Designs, prepares and reviews protocols, methods/processes, experimental and/or authoring plans and/or templates relevant to cryogenics and transportation workflows.
Authors relevant risk assessments and technical reports.
Collaborates with third parties for planning/execution of outsourced shipping studies
Support cryogenics and transportation related site technical investigations, impact assessments, change controls, health authority inspections, and continuous improvement of cold-chain processes.
Provides technical support for product manufacture, validation and technology transfer of cryogenics and transportation processes.
Bachelor’s Degree or equivalent in relevant discipline with a minimum of 6 years of relevant experience. Masters or PhD is preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience
Demonstration of expertise in heat transfer fundamentals is required.
Knowledge of shipping qualification, transportation and packaging design desired.
Knowledge of protein dynamics and stability, especially the effects of freezing and thawing on protein stability desired.
Knowledge of common protein analytical tools and demonstrated experimental skills for lab work is required.
Excellent verbal & written communications skills desired.
Proficient in writing formal reports, articles for publication and technical presentation
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
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Job ID: BHJOB18630_222164
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