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GMP, ASSOC DIR
Job Title: GMP, ASSOC DIR
Job Code: 3002
Job Level: 61
Revised Date: 04/07/2018
Job Family: JF 05
The Associate Director, GMP is responsible for planning, organizing and overseeing the day to day activities relating to the development of new vaccine of clinical therapeutic candidates 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.
Organizes, manages and oversees work of an organizational unit or broad technical area.
Develops operational plan, budget, resourcing for a specific organizational unit.
Coordinates with other functions to deliver programs and projects with a significant degree of complexity.
Develops work plans, assigns & prioritizes work according the program needs and team skill set.
Develops staff and puts together robust succession plans.
Works with Executive management to develop strategic direction and focus.
Organizes communication plans and forums.
Manages and optimizes strategies for efficient review editing and approval of documentation, reports, SOPS.
Develops patents to protect IP participates in and nominates staff for external meetings to raise profile of the team across the field.
Required Qualifications at this Level
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
12 years of experience in the biopharmaceutical or bioprocess industry or equivalent is required with direct experience in process development.
Previous supervisory experience is required.
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 and cGMP production 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 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.