Senior Scientist, Process Development

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Job Description

The Senior Scientist, Purification Process Development & Technology Transfer will provide scientific and technical leadership for the development, scale-up, characterization, technology transfer, and manufacturing implementation of biologics drug substance purification processes.

This role spans the purification process from harvest through bulk drug substance, including harvest clarification, chromatography, virus inactivation, virus filtration, ultrafiltration/diafiltration, formulation, and drug substance final filtration. The successful candidate will combine strong hands-on purification expertise with demonstrated experience transferring drug substance processes to internal manufacturing sites and external partners or contract development and manufacturing organizations and supporting GMP manufacturing execution.

Key Responsibilities

• Serve as the purification technical lead for assigned pivotal and commercial programs, providing scientific direction, identifying technical risks, and communicating recommendations, trade-offs, and mitigation strategies to project and functional teams.

• Lead drug substance technology-transfer workstreams to internal manufacturing sites and external partners or contract development and manufacturing organizations, including process scale-up, facility fit, manufacturing readiness, and transfer execution.

• Lead the development, optimization, scale-up, and characterization of robust, scalable, and manufacturable biologics purification processes.

• Provide hands-on technical leadership across harvest clarification, chromatography, virus inactivation, virus filtration, other filtration operations, ultrafiltration/diafiltration, formulation, and final filtration.

• Design, execute, and interpret process characterization and scale-down studies using appropriate scientific and statistical approaches, including Design of Experiments.

• Establish scientifically justified operating ranges and contribute to the development of integrated process control strategies.

• Develop project plans, coordinate technical activities, manage risks, and deliver purification work products in alignment with program objectives and timelines.

• Provide technical support during engineering, clinical, process performance qualification, and other GMP manufacturing campaigns, including on-site and person-in-plant support as needed.

• Lead or support troubleshooting, deviation investigations, root-cause assessments, and technical investigations related to process performance and GMP manufacturing.

• Author and review development reports, study protocols, process descriptions, technology-transfer documentation, standard operating procedures, manufacturing batch records, and CMC regulatory content.

• Collaborate across Process Development, Manufacturing and MSAT, Analytical Development, Formulation Development, Quality, Regulatory Affairs, Supply Chain, and other CMC functions.

• Mentor junior scientists and contribute to the advancement of purification technologies, platform processes, and organizational best practices.

• Travel as needed to support technology transfers and provide technical oversight at internal and external manufacturing facilities.

Basic Qualifications

• PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biochemistry, or a related scientific discipline with 2 or more years of relevant experience;

• MS in a relevant scientific or engineering discipline with 6 or more years of relevant experience; or

• BS in a relevant scientific or engineering discipline with 8 or more years of relevant experience.

Preferred Qualifications

• Experience in biologics purification process development, characterization, scale-up, and GMP manufacturing implementation.

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