Department
BSD DFI - cGMP
About the Department
Job Summary
Responsibilities
Conduct Quality Control testing and documentation for drug substance and products in a cGMP environment.
Lead and support training for Quality Control related activities and ensure SOP compliance.
Perform end-to-end biomanufacturing processes for live biotherapeutic products (fermentation through final formulation).
Collaborate on process development, optimization, and scale-up of live biotherapeutic production, including media and fermentation improvements.
Operate, maintain, and troubleshoot laboratory and cleanroom equipment and facilities.
Support environmental monitoring, investigations (deviation/OOS), and non-conforming reporting.
Maintain strict adherence to safety, regulatory standards, and quality assurance practices.
Perform equipment maintenance, sterilization, and cleanroom decontamination procedures.
Review manufacturing activities and ensure accurate implementation of procedures and documentation.
Applies standard laboratory procedures to support clinical research studies, such as the preparation of reagents. Handles, processes, banks, and ships patient samples.
Prepares quality and safety control measures for the laboratory, such as checks of equipment, temperature control, and documentation of quality improvement projects. Under a moderate degree of supervision, provides support to clinical research studies.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
---
Preferred Qualifications
Experience:
2+ years of previous hands-on manufacturing experience in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Hands-on experience operating laboratory equipment is highly desirable. This includes operation of anaerobic chambers, bioreactors / fermenters, tangential flow filtration and lyophilization equipment.
In-depth hands-on experience with USP<61> and USP<62> quality control releasing testing for pharmaceutical products.
In-depth hand on experience with Environmental Monitoring (EM) of viable and non-viable sampling.
Experience with anaerobic culturing is desirable.
Understanding microbial fermentation processes and underlying microbial physiology.
Hands-on experience with Vaporized Hydrogen Peroxide (VHP systems).
Hands-on experience in performing laboratory experiments and operating laboratory equipment.
Preferred Competencies
Excellent written and verbal communication skills.
Strong analytical, mathematical, and problem-solving skills.
Exceptional multi-tasking and time-management skills.
Exceptional record keeping, organizational skills, and meticulous attention to detail.
Mature, reliable, and professional demeanor.
Ability to work independently with minor supervision.
Ability to work collaboratively within a team.
Adaptable to changing working situations and assignments.
Ability to train others.
Ability to work in cGMP / cleanroom environment for extended periods of time.
Cleanliness, organization, good laboratory skills, excellent record keeping, and Good Documentation Practices (GDP).
Knowledge of regulatory policies and procedures.
Working Conditions
Laboratory environment.
Physically capable of moving, connecting, and disconnecting gas cylinders.
Application Documents
Resume (required)
Cover Letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.