GMP Analytical Scientist

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

GMP Analytical Scientist
Duke Human Vaccine Institute - Admin

GMP Analytical Scientist, Duke Human Vaccine Institute (DHVI)

Role Description:

The GMP Analytical Team at DHVI is seeking a colleague will work on the development, qualification and execution of analytical and biophysical assays to support the characterization of vaccine products. She/he will provide comprehensive analytical support from the early clone selection stage to the final purification stage of the product. The assays will be suitable for the characterization of quality attributes during downstream process development and for release and stability testing. The successful candidate will have knowledge and hands-on experience in a range of analytical and biophysical techniques, e.g. RP-UPLC, SE-UPLC, CE, glycan analysis, BLI, SPR and SDS-PAGE. The ability to execute and document analytical methods in a regulatory compliant manner is essential.

Responsibilities:
  • Develop and implement robust and reliable analytical assays for the characterization of vaccine quality attributes using a range of potential analytical platforms.
  • Work closely with the upstream and downstream processing teams to provide key analytical information regarding the quality of the potential vaccine product.
  • Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
  • Assist in the development of new methodologies in biophysical and antigenicity testing of vaccine products to advance analytical capabilities
  • Operate in a GMP regulated environment, follow departmental SOPs and Regulatory guidelines.



Requisition Number
401234454

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2466 LAB RESEARCH ANALYST, SENIOR

Job Family Level
14

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: 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.

Education

Work requires a bachelor's degree in biology or other directly related scientific field.

Experience

Work requires five years of research experience. A related master's degree may substitute for three years of the required experience. Must have previous experience managing and leading projects. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Preferences:
  • Work requires a bachelor's degree in biology or other directly related scientific field; Master's degree is plus.
  • Work requires five years of research experience. Must have previous experience managing and
  • Relevant industry experience with a focus on assay development and broad experience with various analytical platforms.
  • Knowledge and hands-on experience working in a GMP environment.
  • Knowledge and hands-on experience developing UPLC methods (reverse phase, SEC, glycan analysis and peptide mapping) is strongly preferred.
  • Knowledge and experience with CE, DSC, DLS, SDS-PAGE and ligand binding assays (ELISA, BLI and SPR) is a plus.
  • Demonstrated ability in solving moderately complex analytical problems.
  • Proven ability to generate high quality data and documentation within challenging time lines.
  • Excellent oral and written communication skills, attention to detail and collaboration skills.


Auto req ID

87585BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: 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.

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