Posted to MedZilla on 3/26/2017


ProClinical

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.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.