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GMP, SCIENTIST/ENG, SR ANALYTICS
Job Title: GMP, SCIENTIST/ENG, SR ANALYTICS
Job Code: 3013
Job Level: 61
Revised Date: 04/07/2018
Job Family: JF 05
The Senior Scientist will lead the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. The incumbent in this position will serve as a scientific leader in all aspects of pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.
Thought leader who envisions new processes and methods for development.
Lead all aspects of analytics or formulation for 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.
Advises management on strategic direction and focus of technical programs.
Develops collaborations with external organizations and 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.
Facilitates team data review and discussion at group meetings and larger team settings.
Leads 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.
Presents extensively at external meetings and/or management forums.
Lead author on publications and patents in a specific area.
Mentors others in developing scientific skills and methods and may manage staff.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
13 years relevant experience in the biopharmaceutical industry or equivalent.
Extensive experience in development of analytical methods and/or product formulations
Demonstrates innovation in the development of analytical methodologies (HPLC, immunoassays, biochemical methods, molecular assays) or pharmaceutical product formulations (buffer & excipient screening, thermal stability evaluation, biophysical methods) is required. Technology transfer & GMP experience is preferred.
Must work independently to devise specific processes or methods in line with strategic program and organizational goals.
Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans.
Superior 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.