Senior Specialist

Description

• Develop and maintain integrated analytical testing schedules by consolidating inputs from multiple digital systems, program priorities, and laboratory capacity to support CMC Development activities.
• Author, review, and manage stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates, supporting shelf-life determination, IND-enabling studies, and product development milestones.
• Generate, review, trend, and interpret analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results and recommendations to stakeholders across CMC Development.
• Manage multiple program timelines simultaneously, ensuring testing milestones, study deliverables, and reporting commitments are completed on schedule.
• Collaborate with cross-functional partners to support forecasting activities, stage-appropriate testing strategies, sample management, and development program planning.
• Design and implement digital tools, automated workflows, and operational processes that improve efficiency, enhance throughput, and support scalable analytical operations.
• Lead efforts to integrate new digital capabilities and improve connectivity between laboratory and enterprise systems, enabling more effective planning and execution.
• Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support method understanding and successful execution of analytical activities.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.
• 6-8 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.
• Experience managing stability studies, analytical testing programs, or laboratory operations within a regulated environment.
• Experience working with LabVantage, Benchling, or similar laboratory information management (LIMS), electronic laboratory notebook (ELN), and data management systems.
• Strong project management, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills with experience presenting technical data to diverse stakeholders.