Scientist, Late-Stage Purification Process Development

Role Summary

The Scientist, Late-Stage Purification Process Development will support characterization and validation of purification processes for late-stage and commercial development of large molecule therapeutics, and author IND/BLA sections. The role collaborates with site, quality, and regulatory functions to drive process consistency, readiness for tech transfer, and high-quality late-stage deliverables.

Responsibilities

• Support purification/downstream process characterization, validation, late-stage/commercial activities.
• Draft protocols, support study execution, review analytical results, generate/review reports, and support IND/BLA section authoring.
• Analyze commercial batch data and support concurrent validation studies.
• Propose and support late-stage or commercial process changes to improve process consistency/performance in collaboration with the site, quality and regulatory functions.
• Support tech transfer for clinical and PPQ campaign readiness.
• Review work from CDMOs as needed to produce high-quality late-stage deliverables.
• Support other late-stage projects and apply lessons learned to current projects.
• Design and execute lab-scale chromatography and filtration studies to inform and support large scale process decisions.
• Maintain existing workflows to provide purification support for cell line and cell culture development activities.
• Execute methods for in-process testing using ELISA, HPLC, UV and SDS-Page based analytics.

Qualifications

• PhD in Biology, Biochemistry, Chemical Engineering, or related scientific discipline with some relevant late-stage purification process development experience in academia/industry or BS/MS with 5+ years of industry experience.
• Experience with purification process characterization or validation.
• Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns.
• Familiarity with BLA authoring or commercial process support is preferred.
• Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs.
• Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies is desired.
• Broad experience in protein characterization, design of experiments and analytical techniques.
• Expertise in AKTA protein purification, tangential and normal flow filter sizing.
• Excellent critical thinking, scientific problem-solving and communication skills.

Skills

• Protein characterization
• Design of experiments and analytical techniques
• AKTA protein purification systems
• Tangential and normal flow filtration sizing
• Analytical method development and execution (ELISA, HPLC, UV, SDS-PAGE)
• Cross-functional collaboration and communication

Education

• PhD in Biology, Biochemistry, Chemical Engineering, or related field; or BS/MS with extensive industry experience in purification process development.