Senior GMP Lab Assistant

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 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

SENIOR GMP LAB ASSISTANT

Duke Human Vaccine Institute

The Senior GMP Lab Assistant will be responsible for ensuring the GMP suites are cleaned in accordance to approved Standard Operating Procedures (SOPs). The cGMP manufacturing facilities produce cGMP cell bank, drug substance, and drug product human clinical supplies for early phase cGMP manufacture of materials for use in human clinical trials of HIV-1 and other infectious disease candidate vaccines. The Senior GMP Lab Assistant will also be responsible for providing general laboratory support to all DHVI laboratory facilities. 

RESPONSIBILITIES: 

• Preparing cleaning solutions following the standard operating procedure (SOP). 
• Routinely cleaning the International Organization for Standardization (ISO)-regulated and non-ISO regulated cGMP rooms and hallway following the standard operating procedure (SOP) (training to be provided). This includes routine monthly cleaning and/or product changeover “Triple” cleans. Cleaning includes mopping of floors, wall, and ceilings and wiping down of door handles and in-suite equipment.
• After cleanings, completing the cleaning logbook following the SOP.
• Notifying supervisor that cleaning activities have been completed to facilitate documentation in campaign readiness plans.
• Notifying supervisor when cleaning materials inventory falls below minimum threshold levels.
• Wearing personal protective equipment (PPE), which may include a respirator, eye protection, zip-up gown, shoe covers, gloves, beard cover (if applicable), and head covering. PPE will be provided. 
• Managing the autoclave validation program for DHVI. 
• Communicating with DHVI staff for Lab Assistant services.
• Contacting E&O for DHVI safety equipment maintenance requests.  
• Leading/assisting on HPV decontaminations in GHRB. 
• Assisting RBL Core Units with basic lab tasks (e.g. labelling tubes). 
• Supporting the RTP site as backup. 
• Completing Select Agent (Tier 1) registration to be fully functional in registered spaces.
• Providing general laboratory support to all DHVI laboratory facilities.
• Processing solid biohazardous waste from laboratories including sterilization by autoclaving and removal from the facility.
• Maintaining clean laboratory spaces.
• Conducting routine performance testing of steam sterilizers (autoclaves).
• Ordering and maintaining ample inventory of safety supplies and personal protective equipment; stocking of these materials throughout the laboratory facilities.
• Documenting weekly performance testing of laboratory eyewashes (and safety showers where applicable).
• Cleaning and processing glassware.
• Conducting routine sterilization of laboratory supplies.
• Performing routine equipment checks in the Protein Purification Facility and GMP facilities.
• Providing routine cleaning of biological safety cabinets.
• Distributing dry ice to applicable laboratory areas.
• Conducting routine safety compliance reviews of DHVI laboratories by use of hardcopy and electronic checklist.
• Performing additional duties as requested by direct supervisor.   

REQUIRED QUALIFICATIONS AT THIS LEVEL:

• Education/Training: Work generally requires a bachelor's degree in botany, biology, zoology, psychology, or other directly related scientific field. 
• Experience: None required above education/training requirement OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATON AND/OR EXPERIECE.

Preferences:

• Prefer up to two years of laboratory experience, preferably in a GMP/regulated environment.  

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.