Department
BSD DFI - cGMP
About the Department
The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing health. By developing new knowledge about the interactions between the human body and the microbiome, the DFI is breaking new ground that will lead to therapies that increase resistance to a wide range of diseases.
Job Summary
The Duchossois Family Institute (DFI) at the University of Chicago seeks a Quality Assurance (QA) Scientist for our current Good Manufacturing Practice (cGMP) facility. This facility is a first of its kind, state-of-the art, adaptable microbiome manufacturing center embedded at the interface of a world-class microbiome sciences research team and patient-centric medical center aimed at translating innovation at the bench to investigations in the clinic. Our objective is to embed a biotech, product development focused capability within an advanced academic research environment, all towards driving value for patients in addressing unmet medical needs in record time. The DFI’s goal is to optimize or augment microbiome functions that enhance disease resistance. The QA Scientist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility. This individual will be responsible for ensuring that manufactured products meet standards of quality, reliability, and safety.
Responsibilities
Develops a comprehensive Quality Management System (QMS) that integrates seamlessly with cGMP production activities.
Leads the creation, evaluation, and optimization of quality assurance protocols, SOPs, batch records, working instructions, and training documents to ensure compliance with all cGMP standards for quality and manufacturing processes.
Collaborates with the purchasing and inventory specialist to ensure raw materials from external suppliers meet quality requirements and performs supplier audits for critical vendors.
Conducts QC inspection of all incoming raw materials and documents the approval release of raw materials for cGMP production and manufacturing use.
Ensures QC testing and validation of raw materials, in-process materials, and finished products are following all regulatory and internal quality standards.
Manages the documentation and change control systems, ensuring all modifications in processes and with equipment are systemically handled and recorded.
Reviews and approves QA-controlled documentation such as SOPs, batch records, working instructions.
Reviews and prepares batch record release documentation.
Develops the appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities.
Manages non-conformance reports (NCRs) and trend non-conforming data regarding product and processes.
Conducts QC testing and inspections of drug substance and finished drug products.
Manages equipment maintenance records and ensures annual equipment calibrations are performed.
Conducts internal audits and prepares for external audits to ensure continuous compliance with cGMP standards, FDA, and other regulatory agencies.
Prepare detailed reports on quality trend, production efficiency, and compliance status for senior management and regulatory agencies.
Collaborate with production and manufacturing team to streamline processes for finished goods drug product.
Engage in optimization production processes to enhance yield and quality of finished good drug product.
Facilitate collaboration between QA, Production, R&D, and Manufacturing teams to ensure seamless operations and quality standards.
Perform hands-on manufacturing operations for Fermentation, Purification, Lyophilization, Encapsulation and Cryopreservation of Live Biotherapeutic Products (LBPs).
Perform routine maintenance of lab equipment including setup, cleaning, decontamination, and appropriate care of equipment.
Perform decontamination protocol for sterilization of cleanroom facility.
Maintain the highest standards of laboratory workplace safety and product quality.
Meet all training requirements for applicable Standard Operating Procedures (SOPs).
Documentation of all manufacturing activities in batch records, logs, and forms.
Follow verbal and written instructions and procedures for processes and equipment.
Develops new tests and evaluates new technology for implementation in diagnostic testing.
Prepares quality and safety control measures for the laboratory, such as checks of equipment, temperature control, and documentation of quality improvement projects. Under a limited 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.
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Work Experience:
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
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Certifications:
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Preferred Qualifications
Education:
Experience:
Previous quality assurance role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.
Understanding of microbial fermentation processes and underlying microbial physiology.
Experience in Bioprocessing Engineering / Biomanufacturing in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.
Experience with bacterial cell culturing, fermentation, and purification (Tangential Flow Filtration) for anaerobic bacteria strains is desirable.
Experience with anaerobic culturing is desirable.
Experience with lyophilization, encapsulation and cryopreservation for anaerobic bacteria strains is desirable.
Experience with bottling, sealing, and labeling of drug products.
Hands-on experience in performing laboratory experiments and operating laboratory equipment.
Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics is a plus.
Hands-on experience with Vaporized Hydrogen Peroxide (VHP systems).
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.
Preferred Competencies
Excellent organizational and communication skills, with a mindset on solving complex biomanufacturing issues.
Being critical and highly accurate.
Strong analytical and problem-solving skills.
Ability to work independently in additional to being a team player.
Strong ability to collaborate with cross functional teams.
Working Conditions
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
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
No
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
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