Posted to MedZilla on 3/26/2017


United States, Associate Director, Analytical Development US_QA_EN_11078-MZ


Our client is seeking an Associate Director/Director to join their Analytical Development department.

Job Overview:

  • The Associate Director should have demonstrated proficiency with development and application of physico-chemical methods for phase-appropriate characterization of protein or vaccine products, including chromatography, capillary- and gel-based electrophoresis techniques, UV/Vis spectroscopy, particle analysis. 
  • The Associate Director will take a leading role in establishing strategy, development and validation of molecular biology and immunoassays for testing vaccine products. 
  • The candidate will be expected to work efficiently with cross-functional teams. 
  • Good understanding FDA and ICH guidelines and practical knowledge with assay validation is required for this position.

Responsibilities include but not limited to:

  • Lead and build team of professionals developing and validating chromatographic, electrophoretic, and other physico-chemical methods for characterization of recombinant protein vaccine products
  • Define strategic goals for the team
  • Participate 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
  • Perform method transfers to QC and other groups and external partners
  • Thoroughly analyze 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
  • Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology
  • Present scientific findings at internal and external meetings

Job Requirements:

  • PhD in analytical science or chemistry or biochemistry. Minimum of 5 years of experience in pharmaceutical, biologics, and/or vaccine development.
  • Strong expertise in development of separation methods for recombinant proteins.
  • Strong assay development skills.
  • Demonstrated managerial experience as well as experience in building teams. 
  • Ability to manage a team of scientists, and develop and motivate scientists to achieve results
  • Demonstrated leadership skills and capable of working collaboratively and cross functionally.
  • 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
  • Strong communication, presentation, and writing skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.
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