Senior Analytical Method Development Scientist, Plasmid & Nucleic Acids

King of Prussia

Summary

The Analytical Method Development Scientist is an experienced scientist that will be responsible for the design, development and execution of advanced analytical techniques that will be utilized to support process development, vector engineering, characterization and release of plasmid batches from manufacturing operations.The scientist will work with cross functional teams for method validation, release and stability specification assays, and additional assays needed to support cell and gene therapy client programs at Center for Breakthrough Medicines. This role requires someone with good knowledge of Microbial and Molecular testing development and scientific understanding of cell and gene therapy products.

Responsibilities

●Design, develop and execute complex analytical methods such as ddPCR, qPCR, NGS, and other advanced techniques.

●Optimize and modify current CBM platform methods for plasmids and other nucleic acids.

●Author test methods, reports, and other required documentation to support implementation of new methods into analytical development and operations.

●Assist with technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs.

●Provide scientific and technical assistance for testing capabilities.

●Participate in and assist with various aspects of method development, transfer, characterization, investigation, and assay validation while collaborating with Vector Engineering, Cell Therapy and Viral Vector Process Development, Testing, Clinical / Commercial Manufacturing, and Quality teams.

●Maintain current awareness of GMP and other regulations, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and products.

●Responsible for some administrative duties for the group.

●Independently applies scientific and/or cross-functional knowledge to achieve project goals.

●Implements strategic departmental research and development goals or ideas.

●Accountable for accomplishing project goals and objectives; anticipates and prioritizes workflow to achieve desired outcomes.

●Assist in implementing strategies, initiatives, and actions to improve processes and procedures to ensure compliance with internal and industry standards.

●Application of advanced scientific knowledge associated with larger and more complex experiments and projects.

Qualifications

●Previous industry or academic experience in pharmaceutical, cell and gene therapy, CAR-T research and development is preferred.

●Experience with analytical methods supporting Plasmids / Nucleic Acids.

●Experience with development of Molecular Methods

● Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management.

●Strategic thinker with excellent problem solving and conflict resolution skills.

●Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.

●Strong troubleshooting and communication skills, highly organized with strong record keeping and an ability to multi-task. Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment.

Education & Experience

Ph.D. or MS in a relevant discipline (Molecular Biology, Microbiology, Cell Biology, Immunology) with minimum 5 + years relevant R&D/microbiology or molecular experience.

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