ProClinical is seeking an Associate Director/Director on behalf of our client. They are looking for someone to join their Analytical Development department to lead the Molecular Biology/Immunoassay group.
- The Director of Immunoassay should have significant experience with biological analysis and characterization of protein or vaccine products with molecular biology techniques and/or immunoassays, including PCR and ELISA-based methods, label-free binding assays, cell-based assays, and enzymatic assays.
- The candidate 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.
Responsibilities include but not limited to:
- Lead and build team of professionals developing and validating molecular biology methods (e.g. PCR and PicoGreen) and immunoassays (e.g. ELISA and SPR) for biological analysis and characterization of recombinant protein vaccine products
- Define strategic group's goals
- Participate in cross-functional workflows and provide scientific guidance to teams
- Develop strategy and assays for process-related protein impurities of expression system for vaccine products
- Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product biological characterization
- Perform method transfers to 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 biological science or biochemistry or molecular biology.
- Minimum of 5 years of experience in pharmaceutical, biologics, and/or vaccine development.
- Strong expertise in development of immunoassays or molecular biology techniques.
- 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
- Ability to critically analyze data using statistical tools and to compile and review technical reports.
- Understanding of FDA regulatory requirements associated with analytical biological analysis and characterization and documentation of vaccine products.
- Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents.
- Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs) is preferred.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
- Good understanding of statistical tools and knowledge of DOE and QbD principles is preferred
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 call Christopher Frank on +1 267 405 6996 or upload your CV on our website 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.