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Job Details

Associate Director, Analytical Development

Company: ProClinical Ltd
Location: Washington DC
Reference: US.SC.DW.10854
Closing Date: 24 Feb 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Our client, a clinical-stage vaccine company, is seeking to attract, develop, and retain talented people who share their passion for science, medicine, and human health. They are looking for an Associate Director/Director to join their Analytical Development department to lead the Separation Sciences group. ...

Requirements:

Our client, a clinical-stage vaccine company, is seeking to attract, develop, and retain talented people who share their passion for science, medicine, and human health. They are looking for an Associate Director/Director to join their Analytical Development department to lead the Separation Sciences group.

Job Role:

This Associate Director, Analytical Development 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 Separation Sciences group
  • 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

Minimal 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
  • 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

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.
In case you have difficulty in applying or if you have any questions, please contact Darren Whyte on +1 646 542 0158 or upload your CV to www.proclinical.com. 

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.

Apply for this job: Associate Director, Analytical Development

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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