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GMP, SCIENTIST/ENG-2, BIOPROCESS
Job Title: GMP, SCIENTIST/ENG-2, BIOPROCESS
Job Code: 3006
Job Level: 92
Revised Date: 04/07/2018
Job Family: JF 05
The Scientist II 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.
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
Downstream techniques 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.
Utilize a broad expertise in bioprocess development and external expertise (vendors, publication) to develop a comprehensive strategy for overall development effort of various candidates with the goal of reducing development cycle times and improving process robustness.
Lead 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.
Analyzes and interprets data and results of individual and team work, utilizing the data in appropriate decision making; summarize data and present results.
Leads 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.
Mentors and develops junior staff.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred.
10 years relevant experience in the biopharmaceutical industry or equivalent.
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.