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Duke University Job Description: |
Job Title: GMP, SCIENTIST/ENG-1, ANALYTICS |
Job Code: 3011 |
FLSA: E |
Job Level: 59 |
Revised Date: 04/07/2018 |
Job Family: JF 05 |
The Scientist I will support the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This incumbent in this position will be involved in all aspects of pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.
Lead pharmaceutical development and successful GMP release including:
Analytical development Develop product specific release and characterization methods
Qualify methods for product release and complete comprehensive characterization of clinical lots.
Complete GMP testing in line with ICH and regulatory guidance.
Formulation development Develop formulations to stabilize vaccine products.
Employ analytical characterization tools to inform product formulation design
Lead formulation & filling of vaccine products including, tech transfer and production under GMP conditions.
Execute and document development and GMP activities in compliance with regulatory requirements.
Leads collaboration with other development teams to provide support for development activities and will work diligently with cell line development and analytical development functions to understand how the process impacts product quality.
Analyze and interpret data and results of individual and team work, utilizing the data in appropriate decision making; summarize data and present results.
Lead writing and review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
Identifies and documents innovations including patenting and publishing of scientific results.
May mentor and develop junior staff.
| Education/Training: | Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred. |
| Experience: | 6 years relevant experience in the biopharmaceutical industry or equivalent. |
| Skills: | Experience in development of analytical methods and/or product formulations Demonstrates innovation in development of diverse analytical methods (HPLC, immunoassays, biochemical methods), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is required. GMP experience is preferred. Must work independently to develop specific processes or methods in line with strategic program goals. Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans. Strong oral and written communication skills |
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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