Director, GMP Facility for Live Biotherapeutic Product Manufacturing
University of Chicago (UC)
Location: Chicago, Illinois
Internal Number: JR13971
Location: Hyde Park Campus
Develops and maintains standards for all major GMP equipment and manufacturing operations. Ensures that appropriate Emergency Coordination and Risk Management procedures are in place.
Develops policies and Standard Operating Procedures (SOPs) for equipment and facility calibration and maintenance.
Ensures proper protocols are followed to maintain compliance with equipment, facility, automation and asset management infrastructure. Reviews facility technical documentation in support of regulatory submissions.
Acts as a liaison with regulatory agencies (e. g., FDA, EMA, EPA, OSHA) and community officials relative to utilities, worker safety, waste removal, permitting, licensing, validation and commissioning of operations. Addresses inquiries by government agencies in a timely manner.
Directs and supervises staff responsible for facility maintenance, process reliability and automation.
Hires staff members and establishes performance expectations. Coaches staff on specific performance and professional development issues. Implements proper training and formal performance management.
Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
Develop and implement programs on cGMP initiatives to improve quality.
Assist in strategic and operational quality planning.
Assist in the introduction, development, implementation of periodic updates in the QA procedures, manual, objectives, and philosophies.
Provide direction and coordination of cGMP quality improvement activities utilizing continuous quality improvement principles and methodologies.
Educate and train employees with their impact in the cGMP quality management system.
Participate in internal and external cGMP quality audits.
Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.
Interface with supplier cGMP quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
Manages research professionals and support staff involved with planning, monitoring, and compliance aspects of research projects. Advises other researchers on long-range plans for research projects.
Develops goals and operating procedures, practices, and guidelines for research activity based on department strategy.
Manages the laboratory facilities, including the purchase of new equipment and the maintenance and repair of laboratory equipment.
Reviews research of others, and may conduct own research, in area of expertise. Edits and approves articles, reports and manuscripts. Presents research findings at meetings and/or conference. Manages the research of processes in clinical or non-clinical settings. Program and use computers to store, process, and analyze data.
Performs other related work as needed.
PhD in Pharmaceutical Sciences, Microbiology, Chemical Engineering, or related discipline.
Understanding of GMPs and regulatory expectations related to live biotherapeutic drug manufacturing processes.
Prior experience in developing lyophilized LBPs or biologic formulations.
Excellent organizational and communication skills.
Strong analytical and problem-solving skills.
Previous mentoring, leadership, or management experience
Experience in biotech engineering/manufacturing environment.
Expertise in live biotherapeutic product (LBP) development, quality control, and production.
Minimum of 2 years of experience in a functional leadership position within one or more areas including Process Engineering, Facilities/Engineering Maintenance, Automation, Validation or related functions.
Demonstrated leadership skills in directing facilities and process support of cGMP manufacturing operations.
Experience managing multiple engineering disciplines and knowledge related to reviewing and approving construction designs, utilities management, maintenance, calibration, equipment installation and specifications.
Skilled at managing the services of external contractors.
Experience supporting manufacturing facilities and utility systems within an FDA regulated environment.
Thorough understanding of cGMP related to Facility design and operation, equipment, utility and cleanroom design operation and maintenance.
Extensive knowledge of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing.
Strong interpersonal and communications skills and ability to present to clients and senior management.
Project Management knowledge.
Excellent supervisory and management skills.
Expertise in regulatory compliance for all IND and SOPs per FDA standards.
Must have physical ability to move compressed gas cylinders
Cover Letter (preferred)
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.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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