Scientist
: Job Details :

This position is grant funded School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. GMP, SCIENTIST/ENG-1, BIOPROCESS Duke Human Vaccine Institute 12-month term-limited position WORK PERFORMED : Leads CGMP Production: process scale up, tech transfer, batch record preparation, and hands on execution of the process under CGMP conditions. Executes and documents CGMP activities in compliance with regulatory requirements. Works with process development and analytical teams to provide support for development activities and transfers processes to CGMP operations. Leads writing and review of technical development reports; writes and reviews protocols for tech transfer, batch records, material specifications. Works with quality team to prepare and review CGMP documents, deviations and CAPAs, SOPs. Analyzes and interprets data and results of individual and team work, utilizing the data in appropriate decision making; summarizes data and presents results to project teams and sponsors. Material and equipment management/readiness to support CGMP campaigns. Mentor and develop junior staff. REQUIRED QUALIFICATIONS AT THIS LEVEL: Education/Training: Bachelor's degree in a science, engineering, or related field. An advanced degree (Master's, PhD) is preferred. Experience: 6 years relevant experience in the biopharmaceutical industry or equivalent. Skills: Experience in development of cell culture or protein purification techniques and analytical techniques; hands on implementation of bioprocess unit operations (bioreactor control and operation, Chromatography, TFF filtration, GE Unicorn software) and/or direct GMP experience is required. Demonstrates innovation in either upstream (cell culture, bioreactor operation including scale up) or downstream purification (chromatography, tangential flow filtration, normal flow filtration) and analytical techniques to support upstream or downstream activities (cell and metabolite analyses, SDS-PAGE, western blot, UV-Vis, colorimetric methods). Must work independently to develop specific processes or methods in line with strategic program goals. Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans. 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 ideasan 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.