School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
The Manager, GMP (Downstream Development Group Leader) 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. This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions. 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.
- Thought leader who envisions new processes and methods for development.
- Lead Downstream aspects of lab scale process development and GMP production including:
- Downstream techniques
- Chromatography development: Resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing.
- Filtration Development: Development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration, sterile filtration.
- GMP Production: Process scale up, tech transfer, and execution of the process under GMP conditions.
- Downstream techniques
- 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.
- Mentors others in developing scientific skills and methods and may manage staff.
- Consults management for strategic direction and focus.
- Leads review of technical development reports; writes and reviews protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.
- Presents extensively at external meetings and/or management forums.
- Develops patents and publications to protect IP and advance the field.
- 8+ years of 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.
- Relevant knowledge and industrial experience in the field of bioprocess development for manufacture of biomolecules and vaccines and experience in transferring processes to cGMP facilities for clinical or commercial manufacture.
- Skills and experience with key bioprocess techniques including; centrifugation (including ultracentrifugation), column chromatography (size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration. Expertise in biomolecule (protein, mRNA, DNA) characterization is a plus.
- Experience with successfully seeing a product through process development and GMP production for early Phase I/II clinical trials.
Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.
8 years of experience in the biopharmaceutical or bioprocess development. industry or equivalent is required with direct experience in process Previous direct or indirect supervisory experience is a plus.
Duke 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 essentialjob 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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