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GMP, MANAGER
Job Title: GMP, MANAGER
Job Code: 3001
FLSA: E
Job Level: 91
Revised Date: 04/07/2018
Job Family: JF 05
Occupational Summary
The Manager, GMP is responsible for planning, organizing and overseeing the day to day activities relating to the development of new vaccine of clinical therapeutic candidates for 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 of clinical vaccine candidates and ensure scientific rigor during execution of cGMP campaigns.
Work Performed
Organizes, manages and oversees technical work of a specific organization unit or technical area.
Develops work plans, assigns & prioritizes work according the program needs and team skill set.
Develops and manages staff.
Consults management for strategic direction and focus.
Organizes and leads group meetings and larger team settings. Leads review, editing and approval of documentation, reports, SOPS.
Manages and optimizes strategies for efficient review, editing and approval of documentation, reports, SOPS.
Develops 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
8 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.
In addition, the preferred candidate will have experience with successfully seeing a product through process development and GMP production for early Phase I/II clinical trials.
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.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
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.
