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GMP, SUPERVISOR
Job Title: GMP, SUPERVISOR
Job Code: 3015
FLSA: E
Job Level: 58
Revised Date: 10/01/2019
Job Family: JF 05
Occupational Summary
The GMP Supervisor is responsible for overseeing the day to day activities to enable cGMP production. The incumbent will work closely with other area managers and senior management to deliver optimized strategies suitable for the cGMP manufacture and ensure scientific rigor during execution of cGMP campaigns.
Work Performed
Oversees technical work of a specific organization unit or technical area.
Administers work plans, assigns & prioritizes work according the program needs and team skill set. Supervises and develops staff. Consults management for strategic direction and focus.
Leads group meetings and smaller team settings. Contributes to review, editing and approval of documentation, reports, SOPS.
Collaborates on strategies for efficient review, editing and approval of documentation, reports, SOPS, policies, procedures, and/or contracts.
Contributes to patents and publications to protect IP and advance the field.
Required Qualifications at this Level
Education/Training
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
Experience
5 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development.
Previous direct or indirect supervisory experience is a plus.
SKILLS:
The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and will have experience in transferring processes to cGMP facilities for clinical or commercial manufacture. They are expected to possess a high level of skill and experience with key bioprocess techniques including; cell culture, cell line development, bioreactor operation and scale-up, centrifugation (including ultracentrifugation), phase partitioning, column chromatography (size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration. Expertise in biomolecule (protein, mRNA, DNA) characterization is a plus.
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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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.