Sr Scientist, Purification Process Development (Pivotal & Commercial)

Key Responsibilities

• Design experiments and demonstrate hands-on technical leadership of all aspects of purification process development including chromatography, TFF, virus filtration, harvest and virus clearance
• Provide scientific and technical leadership of one or more pivotal/commercial programs. Accountable for process characterization strategy, project plans, execution, risk management and delivery of functional objectives throughout the lifecycle including process optimization, process characterization, process performance qualification and technical reports for BLA submission
• Lead and/or support technology transfer, clinical resupply and investigation activities in partnership with Global Manufacturing Sciences and Technology (MSAT)
• Perform statistical analysis and appropriate modeling to assess process parameter criticality, identify acceptable ranges and contribute to the integrated control strategy
• Author and review GMP and non-GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs, etc.) ensuring data integrity and best documentation practices are followed
• Represent the Pivotal & Commercial Purification Development Department on cross-functional product development/CMC teams. Requires collaboration with Analytical Development, MSAT, Cell Culture, Formulation, Manufacturing, Quality, Regulatory, and Supply Chain, as needed.
• May manage direct reports and mentor junior team members on purification process development strategies, experimental design and execution and process transfer
• Help to establish and maintain a state-of-the-art purification lab
• Participate in cross-functional initiatives and business process improvements as needed
• Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities
• Evaluation and implementation of new technologies, workflows, or data approaches to improve development efficiencies and timelines

Basic Qualifications

• Ph.D. with 2+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• OR M.S. with 6+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
• OR BS with 8+ years in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).

Preferred Qualifications

• Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
• Experience in technology transfer of pivotal stage purification processes from 2-25 kL scale including understanding of process scalability, robustness, regulatory expectations, manufacturability and COGs
• Excellent communication, technical writing and presentation skills, and aptitude for creative problem solving
• Experience writing CMC sections of commercial regulatory filings (BLA, MAA) and post approval change filings is desired
• Demonstrated ability to collaborate and influence cross-functionally
• Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire)
• Working knowledge of lab automation, data management, data science, knowledge management and data protection