GMP MANUFACTURING TECH

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 MANUFACTURING TECH

Duke Human Vaccine Institute

OCCUPATIONAL SUMMARY

The GMP technician is responsible for assisting in the delivery of state-of-art manufacturing processes for biological drug products and cellular products for clinical trials and commercial operations. The GMP technician will complete daily, weekly, and monthly support and maintenance activities to ensure facility control and compliance with applicable cGMP guidelines and regulations. This includes, but is not limited to, stocking, moving, cleaning, staging, kitting, and disposing of materials required to produce cGMP cell banks, drug substances, and drug products. The GMP technician will also support preventative maintenance safety-related activities including facilities walkthroughs and inspections, signage management, alarm monitoring, chemical management, and vendor relations related to equipment maintenance. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel vaccination programs and cellular therapies.

RESPONSIBILITIES AND WORK PERFORMED

• Works closely with direct supervisor, Operations, Quality, Analytical Development, and Portfolio Management teams to provide daily on-site support for cGMP materials management and logistics needs; maintains all materials required for cGMP production, including receiving, unboxing, stocking, labeling, and transporting materials throughout the cGMP facility; staging and kitting materials for production use in accordance with SOPs; prepare reports as needed to document material management activities.
• Operate drum lifters, pallet jacks, carts/dollies to support materials management needs.
• Assist in the maintenance of a web-based materials inventory by performing basic data entry tasks for material inventories and inform inventory manager of various stock levels and order status to ensure First In First Out (FIFO) inventory management is maintained.
• Generate material inventory/tracking documents using computers, printers, and inventory management software in accordance with SOPs; maintain outstanding order, purchase order, receiving, requisition, delivery, and shipping files; conduct special and scheduled material inventories and audits of records; provide supervisor with receiving and shipping activity reports as needed.
• Maintains cGMP facilities by executing routine suite activities on a regular basis in the manufacturing areas, controlled storage areas, and uncontrolled support areas; activities to include safety walkthroughs, environmental monitoring sampling, weekly water for injection (WFI) cycles and eye wash station flushes, performs autoclave and washer flushing cycles, assists production staff during manufacturing to complete pH meter, conductivity meter, scale, and turbidity meter daily standardizations and checks, performs pre/post-use biological safety cabinet cleaning during manufacturing campaigns, stock gowning and cleaning supplies.
• Participate in facilities management and oversight by attending alarm monitoring committee and safety team meetings.
• Perform other related duties as necessary and requested by GMP leadership.

The successful applicant will have:

• Good written and oral communication skills.
• Be able to work independently as well as part of a team.
• Be able to communicate and interact in a professional and courteous manner with co-workers and others.
• Be team-oriented and able to work in a highly collaborative work environment to complete complex tasks.
• Be self-motivated, detail-oriented, and well organized.
• Be able to problem solve and operate independently yet escalate when necessary.
• Be able to read, learn and apply technical procedures located in Standard Operating Procedures (SOPs).
• Be able to lift/carry/move cGMP materials weighing up to 50lbs and occasionally ascend ladders to store cGMP materials.
• Demonstrate the highest degree of ethics and integrity at all times.

REQUIRED QUALIFICATIONS AT THIS LEVEL

• 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.

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.