Scientific - Research Scientist

Top Skills:
• PhD with 2+ years of industry experience in molecular assay development, or MS/MA in Molecular Biology or similar with 5+ years of related experience, or BS/BA with 10+ years of related experience.
• Design, develop, and qualify molecular-based analytical methods, including multiplex PCR-based assays using qPCR, RT-qPCR, ddPCR, to support pipeline cell therapies.
• Experience designing and executing experiments to demonstrate assay comparability and to determine assay performance, including the assessment of specificity, accuracy, precision, linearity, and robustness.
• Prepare complex technical documents, including SOPs, test methods, study protocols, and reports.

Position Summary:
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and Client's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
The Molecular Assay Development team is seeking an accomplished (Senior) Scientist to join our team within the Cellular Therapy Analytical Development (CTAD) organization. The (Senior) Scientist will act as a mentor and leader within a team of scientists who are collectively responsible for molecular biology-based QC and characterization methods supporting autologous and allogeneic cell therapies. These methods will be used to further the understanding of cell therapies, support development of the manufacturing processes, and QC release of the drug product. This position is responsible for the technology platform screening, development, qualification, and transfer of molecular biology-based analytical methods; as well as the life-cycle management of these methods. The (Senior) Scientist will have extensive hands-on experience in assay development; possess excellent communication skills; and be able to work with cross-functional teams in order to effectively transfer analytical methods, as well as maintain and troubleshoot existing methods.

Key Responsibilities:
• Design, develop, and qualify molecular-based analytical methods, including multiplex PCR-based assays using qPCR, RT-qPCR, ddPCR, to support pipeline cell therapies.
• Provide leadership and mentorship within a team responsible for assessing new technology, developing molecular biology-based analytical methods, and managing method lifecycle.
• Prepare complex technical documents, including SOPs, test methods, study protocols, and reports.
• Ensure successful transfer of assays to quality control (QC) and commercial teams as needed.
• Establish best practices for molecular biology-based methods by intended use and phase of testing.
• Develop strategies, lead studies, and implement changes to improve existing method performance in development and QC settings to support scalability and reduce resource burden.
• Assist in investigations and troubleshoot molecular-biology based analytical methods by designing and overseeing studies and analyzing data sets with internal colleagues.
• Present development updates and communicate with project leads, project teams, QC teams, operations teams, process development teams and other internal/external collaborators, as needed.
• Analyze data and contribute to complex technical reports and team presentations.

Qualifications & Experience:
• PhD with 2+ years of industry experience in molecular assay development, or MS/MA in Molecular Biology or similar with 5+ years of related experience, or BS/BA with 10+ years of related experience.
• Expert knowledge of and hands-on experience developing and optimizing analytical methods using molecular biology techniques, including various PCR-based methods and/or next-generation sequencing.
• Experience designing and executing experiments to demonstrate assay comparability and to determine assay performance, including the assessment of specificity, accuracy, precision, linearity, and robustness.
• Expert experience writing technical documents, including test methods, SOPs, study protocols, and study reports.
• Track record of successful transfer and management of analytical methods.
• Ability to work effectively and efficiently as a team player in a dynamic environment.
• Strong problem-solving ability in order to troubleshoot complex technical and scientific problems.
• Exceptional attention to detail, strong organizational skills, and a demonstrated ability to complete projects within a timeline.
• Effective communicator.