Principal Scientist, Analytical Sciences (Separation Sciences)
Proclinical is currently recruiting for a Principal Scientist of Analytical Development with a leading biotechnology company located in Gaithersburg, MD. Successful candidate 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.
- 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.
Skills and Requirements:
- MS or PhD in analytical science, chemistry, biochemistry or related field with minimum of 5 years of experience in biopharmaceutical 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.
- Ability to critically analyze data using statistical tools and to compile and review technical reports.
- Ability to define priorities and process to get things done.
- 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.
- 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.
- 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.
In case you have difficulty in applying or if you have any questions, please call Phil Sawyer at (+1) 617-545-5923 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.