Principal Scientist, Biologics Process Development - Downstream Purification

Key Responsibilities

• Serve as the scientific lead for downstream process development programs supporting monoclonal antibodies (mAbs), bispecific antibodies, and recombinant protein therapeutics.
• Provide strategic direction, scientific consultation, and technical oversight across multiple client programs, with a focus on purification process development, scale-up, technology transfer, and commercial readiness.
• Guide the design, development, optimization, and characterization of downstream purification processes, including chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, clarification, and cell removal methodologies.
• Act as the primary technical contact for client development projects, leading meetings, communicating project status, providing scientific rationale, and ensuring alignment between technical execution and program objectives.
• Lead technology transfer activities, process characterization studies, scale-up strategies, validation readiness initiatives, and viral clearance programs supporting progression from development through cGMP manufacturing and commercialization.
• Collaborate with Process Development, MS&T, Manufacturing, Quality, Regulatory, and Analytical teams to drive project execution, troubleshoot technical challenges, and ensure successful project delivery.
• Author, review, and approve technical documents including protocols, reports, SOPs, batch records, and client-facing deliverables while ensuring compliance with Good Documentation Practices (GDP) and regulatory expectations.
• Evaluate emerging technologies, identify opportunities for process enhancement, and contribute to the advancement of scientific capabilities, service offerings, and best practices within the organization.
• Mentor scientists and technical staff, providing coaching, guidance, and knowledge-sharing to support team growth and development.

Required Qualifications

• Ph.D. in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, or a related scientific discipline with a minimum of 8 years of relevant industry experience; master's degree with a minimum of 12 years of experience; or bachelor's degree with a minimum of 15 years of experience.
• Demonstrated industry experience developing, optimizing, scaling, and transferring downstream purification processes for monoclonal antibodies (mAbs), bispecific antibodies, recombinant proteins, or other complex biologic therapeutics.
• Strong expertise in chromatography, filtration, UF/DF, viral filtration, viral clearance, and cell removal technologies.
• Proven experience supporting late-stage development programs, process characterization studies, technology transfer activities, and commercial manufacturing readiness.
• Demonstrated experience operating within a biopharmaceutical, biotechnology, pharmaceutical, or biologics CDMO environment.
• Proven experience leading technical programs and serving as a client-facing scientific representative.
• Demonstrated knowledge of cGMP environments, scale-up activities, and manufacturing support.
• Excellent scientific communication, problem-solving, and project management skills.

Preferred Qualifications

• Experience in a biopharmaceutical, biotechnology, pharmaceutical, or CDMO environment supporting biologics manufacturing.
• Experience with industrial-scale purification processes for monoclonal antibodies, bispecific antibodies, and/or recombinant proteins.
• Track record of leading cross-functional teams and mentoring scientific staff.
• Experience supporting multiple client programs simultaneously.
• Expertise in viral clearance studies, late-stage process development, process characterization, commercial manufacturing readiness, and lifecycle management.
• Strong business acumen and ability to build client relationships.
• Experience partnering closely with Manufacturing Science & Technology (MS&T) and manufacturing operations teams during technology transfer and commercialization activities.