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GMP, ASSOC SCIENTIST/ENG-2, BIOPROCESS
Job Title: GMP, ASSOC SCIENTIST/ENG-2, BIOPROCESS
Job Code: 3004
Job Level: 86
Revised Date: 04/07/2018
Job Family: JF 05
The Associate Scientist II will support 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.
Perform 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.
Design experiments, execute and document development and GMP activities in compliance with regulatory requirements.
Support CGMP production, including equipment and material management, to ensure facilities and materials meet DHVI needs, perform investigations.
Provide support for cGMP campaigns, including documentation, deviation and root cause analysis.
Collaborate closely 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 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. A Master's degree is preferred.
4 years relevant experience in the biopharmaceutical industry or equivalent.
Experience in development of cell culture or protein purification techniques and basic analytical techniques; hands on implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is preferred
Experience 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 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.