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Biologist
Southborough, MA

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EPM Scientific

Principal Scientist Upstream Process Development - Biologics

Job Description

Principal Scientist, Upstream Process Development About the Opportunity Our client is a rapidly growing biologics-focused organization seeking a Principal Scientist to provide technical leadership within its Upstream Process Development function. This individual will lead process development activities, drive innovation, mentor junior scientists, and play a key role in advancing biologics programs from development through manufacturing. Key Responsibilities Lead the design, execution, analysis, and optimization of upstream process development studies for biologics programs. Provide technical leadership across cross-functional development teams and support strategic project objectives. Oversee bioreactor operations, process scale-up activities, and technology transfers to manufacturing environments. Analyze experimental data, prepare technical reports, and communicate findings to internal stakeholders and leadership teams. Evaluate and implement new technologies, scientific advancements, and process improvements to enhance development capabilities. Qualifications BS, MS, or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related scientific discipline. Significant industry experience in upstream process development, process scale-up, and technology transfer within biotechnology, biopharmaceutical, or related environments. Strong expertise in mammalian cell culture, bioreactor operations, process optimization, and commercial manufacturing support. Experience operating within cGMP environments and supporting late-stage or commercial biologics programs. Demonstrated technical leadership, project management, and mentoring experience. Strong communication, problem-solving, and cross-functional collaboration skills. Experience with statistical analysis and DoE tools such as JMP, Minitab, or similar platforms is preferred. Ideal Background Deep understanding of biologics process development and manufacturing. Proven success supporting process scale-up, technology transfer, and lifecycle management activities. Ability to operate in a fast-paced, scientifically driven environment while balancing multiple priorities. Passion for innovation, continuous improvement, and team development.