Principal Scientist (Analytical Separation Sciences)

Hobson Prior are currently working with a late-stage biotech organisation specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. Our client is seeking a Principal Scientist (Analytical Separation Sciences) to join them on a permanent basis based in Maryland.

Job Responsibilities:

• Oversee professionals developing and validating chromatographic, electrophoretic, and other physico-chemical methods for characterization of recombinant protein vaccine products.
• Define strategic goals for the Separation Sciences group.
• Partake in cross-functional workflows and provide scientific guidance to teams.
• Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product characterization.
• Complete method transfers to QC and other groups and external partners.
• Thoroughly analyse results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics.
• Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations.
• Write, edit, and review analytical sections of CMC regulatory filings.
• Uphold effective communication with process development, formulation development, QC, QA, research, and clinical immunology.
• Present scientific findings at internal and external meetings.

Key Skills:

• Demonstrated managerial experience as well as experience in building teams.
• Capability to critically analyse data using statistical tools and to compile and review technical reports.
• Ability to define priorities and process to get things done.
• Strong assay development skills.
• Excellent communication, presentation, and writing skills
• Excellent record keeping abilities to adequately record, analyse, and document analytical data generated in support of regulatory requirements.

Requirements:

• MS or PhD in analytical science, chemistry, biochemistry or related field with minimum of 5 years of experience in biopharmaceutical and/or vaccine development.
• Strong expertise in development of separation methods for recombinant proteins.
• Understanding of FDA regulatory requirements associated with analytics and characterization and documentation of vaccine products. Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents is preferred.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred.
• Good understanding of statistical tools and knowledge of DOE and QbD principles is preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.