Job Description 12,000. The number of associates worldwide working together to reimagine medicine!
The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
The Senior Expert, Science & Technology - MolBio, Initiates, directs and executes the Development and optimization of phase-appropriate molecular biology assays for the lot release, stability testing and characterization of drug substance/drug product. Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.
Your responsibilities include, but are not limited to:
• Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
• Plans and executes laboratory research.
Initiates, directs and executes the development, optimization, qualification of robust molecular assays (i.e. NGS, qPCR, ddPCR and/or other molecular assay platforms) for DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AAV-based gene products
• Conducts work in compliance with cGMP, safety and regulatory requirements.
• Participates in activities such as RNA isolation, cDNA library construction, library amplification, genomic DNA isolation, polymerase chain reaction, and other standard molecular biology techniques.
• Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings.
• Able to troubleshoot experiments based on thorough understanding of assay principles
• Authoring of technical reports and SOPs associated with the molecular assays developed and qualified .
• Communicates and partners with cross-interdisciplinary teams to include, but not limited to engineering, regulatory compliance, scientists and other professionals
• Serve as SME of molecular assays in support of technology transfer of methods to internal QC group and/or CROs and subsequent trouble-shooting, as needed.
• May act as spokesperson on corporate research and development and advise top management.
• Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed
• Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable.
• Maintains broad knowledge of state-of-the-art principles and theories.
• Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.
• Makes major contributions to scientific literature and conferences.
• Other related job duties as assigned.