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Duke University and Duke University Health System require all students, faculty and staff to receive the COVID-19 and influenza vaccines.  After you have officially accepted a position at Duke, you may request a religious or medical accommodation.

GMP MANUFACTURING TECH

Work Arrangement: 
Requisition Number:  186733
Regular or Temporary:  Regular
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER
Date:  Aug 4, 2022

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.

 

Occupational Summary

The GMP Technician will provide in-suite production support required for multiple cGMP manufacturing facilities which 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.  This position will be responsible for execution of various cGMP production support tasks required to execute a large portfolio of products.

Work Performed

Collaborates closely with the cGMP Tech Transfer team to provide daily on-site support for cGMP production needs.

Provides hands on support of production activities, including unit operation set-up and breakdown for water runs, training runs, engineering runs, and GMP runs. Provides additional ancillary manufacturing support during active processing as needed, such as transfer of samples / materials in real-time. 

Performs sample aliquots for production activities using good aseptic technique within a BSC, as needed. 

Performs Filter Integrity Tests (FIT) in support of production activities. 

Manufactures in-house buffer/media in support of production activities.

Manufactures sterile assemblies, as needed, to support production needs if outsourced sterile assembly suppliers are constrained. 

Ensures logbooks are closed out in a timely manner, replenished as needed to support production activities. 

Performs routine production instrument upkeep, standardization, and kit change out for cell culture equipment (i.e. ViCells, Nova Bioprofiles, etc).

Completes pH meter, conductivity meter, scale, and turbidity meter daily standardizations/checks. 

Performs pre/post-use BSC cleans during manufacturing campaigns, as needed. 

Performs manufacturing suite cleanout as part of product changeover / line clearance, post manufacturing.

Assist with cleaning materials into the facilities, staging materials, and kitting materials for production use.  

Abides by 5S organization of supplies/materials throughout the cGMP facilities.  Routinely organizes areas to keep all production areas tidy, adequately segregated, and ensure First In First Out (FIFO) is maintained. 

Assists with the upkeep of cGMP facilities on a daily/weekly/monthly/quarterly basis, through the performance of routine production support tasks within the cGMP production areas.  Basic equipment use, good documentation practices (GDP), and the ability to manage a cadence of task execution will be required for this role. 

Assists with cleaning in of materials/equipment for production facilities in accordance with Standard Operating Procedures (SOPs). 

Assist in inventory of production materials and gases. Assist in special and scheduled material inventories; inform materials & logistics lead of various production material stock levels and assist in maintaining production material outstanding orders.

Perform other related duties as necessary and requested by GMP leadership.

Required Qualifications at this Level

Education/Training:

High School degree

Associates degree in a science, bioprocess, or related field preferred.

 


Experience:

None

 


Skills:

  • 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 times

 

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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh