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Job Title: GMP, DIRECTOR
Job Code: 3019
Job Level: 98
Revised Date: 09/22/2020
Job Family: JF 05
The Director, GMP is responsible for planning, organizing and overseeing the day to day activities of a multidisciplinary team leading to the development of new vaccine of clinical therapeutic candidates. The incumbent will work closely with Institute management and coordinate efforts of area managers and scientists to deliver optimized strategies suitable for the cGMP manufacture of clinical vaccine candidates and ensure scientific rigor during execution of cGMP campaigns. Responsible for technical, financial and operational management of the organization.
Develops a plan for management and operation of an organization unit with a significant scope.
Develop and manage budget and personnel resourcing for execution of the teams programs.
Communicate status of projects and coordinates with multiple functions externally and internally to deliver programs and projects with a significant degree of complexity.
Sets vision for the organization unit to deliver current and future project needs in alignment with the Institutions Goals.
Develops staff and assembles robust succession plans for active organizational management.
Supports pursuit of future funding sources & collaborators and assists in authoring business proposals to support programs.
Manages and optimizes strategies for efficient review editing and approval of documentation, reports, SOPS.
Develops IP protection through patents and develop organizational reputation through publications and leading meetings in the field
Required Qualifications at this Level
Bachelor degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
15 or more years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in product development. Previous supervisory experience is required.
The ideal candidate will have broad knowledge and industrial experience in the field of biologics development including manufacture of biomolecules and vaccines and 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, analytical methods and cGMP production including; bulk drug substance production, drug product fill/finish and analytical release. Expertise in biomolecule characterization is a plus.
In addition, the preferred candidate will have experience with successfully seeing a product through process development and 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.
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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.