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GMP, SCIENTIST/ENG, PRINCIPAL BIOPROCESS
Job Title: GMP, SCIENTIST/ENG, PRINCIPAL BIOPROCESS
Job Code: 3008
Job Level: 94
Revised Date: 04/07/2018
Job Family: JF 05
The Principal Scientist will lead the development, tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.
A subject matter expert, recognized across the field as a thought leader who envisions new concepts, processes or methods.
Lead Upstream and/or Downstream aspects of lab scale process development and GMP production including:
Upstream techniques Cell culture development (ex. CHO, 293, insect cell)
Growth media selection and optimization
Derivation and characterization of stable cell lines
Chromatography development: Resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing.
Filtration Development: Development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration, sterile filtration.
GMP Production: Process scale up, tech transfer, and execution of the process under GMP conditions.
Advises management on strategic direction and focus of technical programs.
Identifies and 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. Provides insight as an external reviewer, and provides perspective to de-risk programs
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.
Widely known as an expert in the field, may serves in an advisory role in professional organizations. Presents extensively at external meetings and/or management forums.
Extensive patent and publication record and/or external reputation in a specific field or expertise area.
Mentors junior technical leaders, 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.
16 years relevant experience in the biopharmaceutical industry or equivalent.
Extensive experience in development of cell culture or protein purification techniques and analytical techniques; experience leading implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is required
Demonstrates innovation in either upstream (cell culture, bioreactor operation including scale up) or downstream purification (chromatography, tangential flow filtration, normal flow filtration) and analytical techniques to support upstream or downstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis, colorimetric methods.)
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.
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.