Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
6 Years
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
Highest qualification: University
- 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.
Preferred Skills
- Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities.
- Knowledge of CMC Development, stability programs, and regulatory requirements supporting IND submissions and product development.
- Experience with process automation, workflow optimization, data visualization, or digital transformation initiatives.
- Demonstrated ability to analyze, trend, and interpret analytical data to support scientific and operational decision-making.
- Experience leading or supporting cross-functional programs and projects, including planning, prioritization, stakeholder management, risk mitigation, and execution against key milestones.