This Position is Fully Grant Funded

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.

Duke Human Vaccine Institute

The Process Development Technician will prepare in-process materials, draft and issue pivotal documentation such as batch records, and ensure overall readiness for impending development campaigns. Process development designs and develops suitable processes of novel vaccine constructs for HIV, influenza and other infectious diseases to enable GMP manufacture and supply in support of early phase human clinical trials. Upstream process development (USPD) develops cell lines and leverages plasmids to develop suitable production process chains to produce a drug substance for cGMP manufacture. USPD also develops processes for final drug product cGMP manufacture. Downstream development (DSPD) develops suitable purification processes and formulations for final drug substance and drug product cGMP manufacture. This role will provide daily/weekly/monthly readiness support to enable efficient process development activities; this position will be responsible for pre-execution activities to support a large portfolio of products in development.

• Collaborates closely with process development scientists to ensure in-process materials are prepared prior to the execution of various development campaigns. This role will assist staging in-process materials and kits in preparation for development activities. This will include buffer preparations, filtration setups, general chromatographic skid configuration and upstream equipment setups. This role ensures overall readiness prior to development campaign execution in both upstream and downstream process development.
• Collaborates closely with process development scientists to draft and issue required documentation in preparation for development activities. This role will draft batch records, organize and sustain good documentation best practices in electronic notebooks, equipment logbooks, and batch records in a timely manner. This role will ensure final process verification development records are sufficient to supply compliant material for pre-clinical and toxicity studies.
• Ensure overall laboratory readiness to support diverse empirical work conducted in process development in collaboration with the other technician and staff scientists. This includes assisting with raw material inventory management, post campaign disposal and cleanup, contributing to after action reviews to cultivate continuous improvement.

• Education/Training: Work generally requires a bachelor's degree in science, engineering, or related field.
• Experience: None required above education/training requirement. Prefer up to two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of experience.

• Must be self-motivated, detail-oriented, drawn to routine, well organized, have strong communication skills and ability to work in an interactive team environment.
• Must have the ability to problem solve and operate independently, yet escalate when necessary
• Must be able to learn and apply technical procedures located in Standard Operating Procedures (SOPs)
• Must be able to lift/carry/move cGMP materials weighing up to 50lbs and occasionally ascend ladders to store cGMP materials

Must demonstrate the highest degree of ethics and integrity at all time

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.