Job description

The Biological Sciences Division at the University of Chicago is hiring a full-time Biomanufacturing Scientist to join the team!

Job Summary

The job manages laboratory data collection and analysis to support clinical research, and assists in specialty research involving animals, MRI technologies, histology, among others.

Responsibilities

• Develop scalable anaerobic fermentation cultures including inoculum ratio and feeding strategies.
• Design and implement processes to optimize media and fermentation conditions for anaerobic bacteria strains to grow on large scale.
• Design and lead the scale-up fermentation and purification processes for anaerobic bacteria strains in anaerobic environments.
• Develop the scale up lyophilization, encapsulation and cryopreservation processes for anaerobic bacteria strains in anaerobic environments.
• Perform routine maintenance of lab equipment.
• Establish in-process QC testing and inspection such as bacterial gram stain check and yield check by CFU.
• Establish Standard Operating Procedures (SOPs) and specifications for various manufacturing activities such as microbial Inoculum, Fermentation and Purification processes.
• Establish Standard Operating Procedures (SOPs) and specifications for various equipment used for the production of Drug Substance and Drug Products.
• Maintain records of executed work and activities as outlined per Standard Operating Procedures that supports QA, QC, and regulatory requirements.
• Collect, compile, and analyze relevant manufacturing data and drive process improvement activities.
• Review existing processes, specifications, and documents to identify improvement opportunities.
• Work closely with Quality Assurance Specialist to ensure compliance with FDA and regulatory standards.
• 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.

Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.

Education:

• B.S. degree in Microbiology, Biochemical Engineering, Bioengineering, or related field.
• M.S. degree strongly preferred.

Experience:

• 5+ years of previous Bio-processing Engineering/Bio-manufacturing experience 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.

​Preferred Competencies

• Excellent organizational and communication skills, with a mindset on solving complex biomanufacturing issues.
• Strong analytical and problem-solving skills.
• Strong ability to collaborate with cross functional teams.

Working Conditions

• Office Environment.
• Laboratory/cleanroom environment.

Application Documents

• Resume (required)
• Cover Letter (preferred)

Job Family

Research

FLSA Status

Exempt

Pay Frequency

Monthly

Scheduled Weekly Hours

40

Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

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.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

COVID-19 considerations:
Employees must comply with the University’s COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward.

Education:

• Associate (Preferred)

Experience:

• Cell culture: 1 year (Preferred)
• bioengineering / biomanufacturing: 5 years (Preferred)

Work Location: One location

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