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GMP, ASSOC SCIENTIST/ENG-2, ANALYTICS
Job Title: GMP, ASSOC SCIENTIST/ENG-2, ANALYTICS
Job Code: 3010
Job Level: 68
Revised Date: 04/07/2018
Job Family: JF 05
The Associate Scientist II 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 pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.
Perform 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.
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.
Design experiments, execute and document development and GMP activities in compliance with regulatory requirements.
Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
Write and reviews technical development reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
Supports innovations including patenting and publishing of scientific results.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field.
An advanced degree (Master's, PhD) is preferred.
4 years relevant experience in the biopharmaceutical industry or equivalent
Experience in development of analytical methods and/or product formulations
Hands on experience with 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 have the ability to works independently to develop specific processes or methods with limited guidance from senior scientists/managers.
Demonstrated ability in solving complex analytical problems with guidance from senior development scientists.
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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Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.