Clinical Manufacturing Operations Director
3 weeks ago
Department
BSD DFI - Staff
About the Department
The Duchossois Family Institute (DFI) at the University of Chicago is using cutting-edge technologies and developing facilities to accelerate clinical research and introduce novel interventions that optimize microbiome-mediated host defenses, with the goal of enhancing human 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
**Responsibilities**:
- Responsible for supervising and managing a team of professional staff who perform technical laboratory procedures to assure compliance in drug manufacturing processes.- Provides technical guidance to staff, colleagues, and clients.- Works directly with leaders, faculty, and clinical staff to prioritize facilities and equipment requirements for LBP manufacturing.- Develops goals and executes operating procedures, practices, and guidelines for all clinical manufacturing activities.- Executes a comprehensive GMP facility master plan to optimize resources.- Maintains all Engineering Standards for GMP facilities and manufacturing operations. Ensures appropriate Business Continuity Planning, Emergency Coordination and Risk Management procedures are in place.- Enforces policies and Standard Operating Procedures (SOPs) for equipment and facility calibration and maintenance.- Ensures proper biological and safety protocols are followed to maintain compliance with equipment, facility, and asset management infrastructure. Reviews facility technical documentation in support of regulatory submissions.- Oversees the investigations of facility, equipment, and process deviations for the development of corrective actions to prevent re-occurrences and change management for any changes to qualified systems and process equipment in order to maintain equipment, facility and systems in a validated state.- Acts as a liaison with regulatory agencies (e.g., FDA) and community officials.- Manages maintenance records for equipment, facility, and systems is to keep operations optimized.- Hires and establishes performance expectations for staff members. Coaches staff on proper training, performance, and professional development.- Actively promotes safety rules and awareness by demonstrating good safety practices at all times including appropriate use of protective equipment.- Reports and takes initiative to correct safety and environmental hazards.- Manages the administration of the database(s) and subscribers, including the team's installation and maintenance of hardware and software.- Manages user support. Ensures that the team provides prompt and effective answers and issue resolutions to incoming questions.- Perform 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 7+ years of work experience in a related job discipline.
- Certifications:
- Preferred Qualifications
**Education**:
- Advanced degree in Pharmaceutical Sciences, Microbiology, Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline.
**Experience**:
- Previous role in biopharmaceutical development or manufacturing setting, either academic or industry, with a focus on developing biotherapeutics for clinical investigation.- Hands on experience with GMP manufacturing and/or bioprocess development related to live biotherapeutic processes.- Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics.- Prior experience in Microbiology including familiarity with Bacterial Culturing, Culture Media Preparation and Selection, Bacterial Viability and Stability Determination and ability to interpret data resulting from a range of Bacterial Functional Assays.- Prior experience in developing lyophilized LBPs or biologic formulations.
Preferred Competencies- Demonstration of a high degree of flexibility, adaptability, and a willingness to learn and being both the ‘coach and player’ on the field.- Excellent organizational and communication skills, with a mindset of driving performance and innovation in a lean and highly effective team setting.- Strong analytical and problem-solving skills.- Strong team building, mentoring, leadership, or management experience.
Working Conditions- Onsite, regular attendance.- GMP facility, laboratory environment.- Must have physical ability to move compressed gas cylinders.- Occasional weekend/evening hours necessary to complete time-sensitive projects.
Application Documents- Resume (required)- Cover Letter (required)
Job Family
Research
Role Impact
People Manager
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
No
Health Screen Requi
-
Director of Manufacturing Operations
4 weeks ago
Chicago, United States Farmer's Fridge Careers Full timeFarmer’s Fridge makes fruits and vegetables accessible and approachable for everyone. We offer a variety of fresh, healthy, ready-to-eat meals and snacks through our fresh food vending machines, wholesale partners, and our office pantry solution — providing chef-curated meals to customers within seconds. Today, we operate a network of Fridges and partner...
-
Director, Manufacturing and MSAT
2 months ago
Chicago, United States Page Mechanical Group Inc Full timePosition Overview The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...
-
Director, Manufacturing and MSAT
2 weeks ago
Chicago, United States Page Mechanical Group Inc Full timePosition Overview The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...
-
Director, Manufacturing and MSAT
2 months ago
Chicago, IL, United States Page Mechanical Group, Inc. Full timePosition Overview The Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. As a company liaison to CMOs, the Director ensures...
-
Remote Manufacturing Planning Director
2 months ago
Chicago, IL, United States Page Mechanical Group, Inc. Full timeThe Director, Manufacturing and MSAT will work in a dynamic, small team supporting external manufacturing of Medexus’ Products. The Director, Manufacturing and MSAT is responsible for day-to-day management of direct reports and contract manufacturing organizations for Medexus products. The Director will provide technical and scientific subject matter...
-
Manufacturing Engineer
1 month ago
Chicago, United States Manufacturing Engineer Full timeSeeking to hire a Process Engineer for a direct hire opportunity in Chicago, IL.The Process Engineer will be responsible for maintaining, developing, and operating manufacturing systems to keep production costs down, while maintaining the quality of products. Will make recommendations to improve productivity and efficiency of operations. Essential Duties and...
-
Director, Clinical Operations
1 month ago
Chicago, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Director, Clinical Operations
1 week ago
Chicago, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Director of Operations
3 weeks ago
Chicago, United States Round-Peg Solutions (RPS) Full timeAre you an Operations Manager, who is ready to step into a Director of Operations role, or already a Director of Operations looking for a new exciting challenge? RPS has been retained by a multi-billion dollar, global Aerospace Manufacturer based in Illinois, to find their next Director of Operations to join them at an exciting time of growth and expansion....
-
Director of Operations
3 weeks ago
Chicago, United States RK Partners Full timeJob Description Job Description Director of Operations Our success continues to be driven from within, starting with our dedicated employees who operate with a sense of urgency, commitment to customers and flexibility to do what is right. Founded in 2014, we are a high growth, privately held operator of world-class diversified industrial businesses. Our...
-
Director of Store Operations
1 week ago
Chicago, United States Eataly Net USA, LLC Full timeThe Director of Store Operations oversees all aspects of the complex operations of an Eataly. Together with senior leadership, the Director plans and executes strategies to drive sales, increase profitability, and cultivate a positive experience for Operations, Director, Store, Operation, Store Leader, Manufacturing
-
Chicago, United States Dhaliwal Laboratories Full timeJob DescriptionJob Description Dhaliwal Laboratories is a high growth multi-site contract manufacturer of personal care products. Prior experience in leading manufacturing organization in personal care or food manufacturing. Engineering background preferred. Directs all aspects of the business operations, including engineering, facility maintenance,...
-
Director of Operations
3 weeks ago
Chicago, United States Sterling Engineering Full timeTitle: Director of Operations Location: Chicago, IL (Onsite, 1 day remote per week) Salary : $145k - $160k + bonus Overview: Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional...
-
Director of Operations
2 weeks ago
Chicago, United States Sterling Engineering Full timeTitle: Director of Operations Location: Chicago, IL (Onsite, 1 day remote per week) Salary : $145k - $160k + bonus Overview: Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional...
-
Director of Operations
2 weeks ago
Chicago, United States TalentRemedy Full timeThe Director of Operations will play a pivotal role in leading and optimizing the production and fulfillment operations of our client's company. This position requires a leader with extensive experience in manufacturing and supply chain management, a proven track record of driving operational excellence and a strategic mindset to support business growth and...
-
Director of Operations
1 week ago
Chicago, United States TalentRemedy Full timeThe Director of Operations will play a pivotal role in leading and optimizing the production and fulfillment operations of our client's company. This position requires a leader with extensive experience in manufacturing and supply chain management, a proven track record of driving operational excellence and a strategic mindset to support business growth and...
-
Director of Operations
8 hours ago
Chicago, United States TalentRemedy Full timeThe Director of Operations will play a pivotal role in leading and optimizing the production and fulfillment operations of our clients company. This position requires a leader with extensive experience in manufacturing and supply chain management, a proven track record of driving operational excellence and a strategic mindset to support business growth and...
-
Director of Operations
2 weeks ago
Chicago, United States TalentRemedy Full timeThe Director of Operations will play a pivotal role in leading and optimizing the production and fulfillment operations of our client's company. This position requires a leader with extensive experience in manufacturing and supply chain management, a proven track record of driving operational excellence and a strategic mindset to support business growth and...
-
Director of Operations
1 week ago
Chicago, United States TalentRemedy Full timeThe Director of Operations will play a pivotal role in leading and optimizing the production and fulfillment operations of our client's company. This position requires a leader with extensive experience in manufacturing and supply chain management, a proven track record of driving operational excellence and a strategic mindset to support business growth and...
-
Clinic Director
2 weeks ago
Chicago, United States Horizon Health Corporation Full timeClinic Director- New Outpatient ClinicHorizon Health is seeking a Program Director for our outpatient mental health clinic called Thousand Branches Wellness in Chicago, IL. This is a BRAND NEW clinic opening summer of 2024 and we are looking for someone to join our senior leadership team now to assist with the opening process and oversee the clinic! This...
