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