Data Systems Senior Scientist/Sr. Specialist - Regulatory Affairs

Job Description

Job Description

Data Systems Senior Scientist (P3), Regulated Bioanalytics, Integrated Logistics & Sample Management (ILSM) 

Description

The PDMB Regulated Bioanalytics Department is seeking a Data Systems Senior Scientist to join our Integrated Logistics and Sample Management group.  This role will support work across groups within the Regulated Bioanalytics Department, including work at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA.  At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.  As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our Company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA. 

The primary role of the successful candidate will be to provide data management and automated solutions to support the development and implementation of tools to increase the efficiency of processes, data review, and data visualization that can be applied to increase the throughput of our Vaccines pipeline.   The individual should have  demonstrated experience in applying software solutions to address scientific challenges and enhance productivity.   

Education Minimum Requirement

PhD in Biological Sciences, Biomedical Engineering, Data Sciences, Computer Science or related area, or an MS degree with 2+ years, or BS degree with 4+ years of relevant experience 

Responsibilities

• Represents ILSM in early/late vaccine development teams and influences data strategies together with stakeholders 

• Communicates results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams 

• Provides scientific input of strategy, development, and validation of IT solutions for visualization tools for the review of experimental data and for IT tools used to track material through automated systems 

• Designs, assesses, and implements novel approaches and technology for data management, bioanalytical systems, data insight tools, and other applications required during non-clinical and clinical bioanalytical testing. 

• Benchmarks current approaches/techniques to the industry standards  

• Remains current in the field and maintains an external presence in the field of data management 

• Identifies opportunities for new collaborations, engages collaborators, identifies business needs and values, and proposes proper solutions 

Required Experience & Skills

• Understanding of statistical methods to analyze and visualize large data sets 

• Experience in algorithm development and implementation 

• Experience with software visualization programs 

• Knowledge and hands-on experience in areas such as discrete mathematics, constrained multi-objective optimization, dynamical modeling and simulation, machine learning, pattern recognition, data mining, and statistics 

• Familiarity with computer control concepts to assist in troubleshooting and implementing computer-based lab automation and instrumentation 

• Excellent oral and written communication skills; ability to work independently and collaborate with stakeholders to implement data strategies that enhance efficiency 

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment 

• Working knowledge of regulatory and industry guidelines in the area of bioanalytical testing, preferably in the vaccines field  

Preferred Experience & Skills

Project management skills

#ProjectADVANCE

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