Quality Assurance Manager
University of Chicago
The Cyclotron Facility at the University of Chicago is the only academic Cyclotron Facility in the state of Illinois and has been operational since 2017. The Facility manufactures radioactive pharmaceuticals for human (and animal) use. The Facility holds its own FDA approved Investigational New Drug (IND) application for one human use, clinical-trial radiopharmaceutical and is listed as the manufacturer on the INDs of three other INDs that are held by other Institutions and are also for clinical trials involving humans.
About the Department
While we produce IND drugs for humans, plans are being executed to produce clinical drugs for use here at the Hospital of the University of Chicago. Regulatory compliance for clinical drugs is similar, but more stringent, than the requirements for IND drugs. Therefore, experienced personnel are critical to operations and regulatory compliance.
Our staffing requirements are highly unusually. For this position, the applicant needs to have skills in 1) chemistry, pharmacy, or biochemistry/molecular chemistry, 2) microbiology/chemistry experience, 3) experience with regulatory affairs, procedural reviews, and audits, 4) experience in working in high levels of radiation and with large amounts of radioactivity is very desirable, but not required, and 5) and clear ability to work in a complex, sometimes high-stress, and multiple-worker environment for example a pharmaceutical production facility, a pharmacy, or a Cyclotron Facility would all be appropriate.
This position is for a manager level Quality Assurance professional who also has scientific skills. The candidate should have experience in drug manufacturing, radiopharmaceutical production, and/or chemistry/biochemistry/microbiological experience. The candidate will develop and maintain a robust Quality Assurance Program for our drug production but will also be expected to participate in direct Quality Control testing of our drugs. The candidate will also oversee all scheduling activities and purchasing of supplies, reagents, and chemicals in collaboration with the Director and Associate Director of the Facility. The candidate must be experienced in analytical testing and have demonstrated science experience in an appropriate field applicable to our drug productions. The candidate will be responsible for developing a robust training program in consultation with the Facility Director that covers all aspects of operations. The candidate will be trained in: radiation safety, to operate our particle accelerator used in our radiopharmaceutical production and in the drug production processes also. Excellent organizational and communications skills and meticulous following of Standard Operating Procedures are required.
Manage the Cyclotron Facility with emphasis on Operations and Quality Assurance.
Oversee and manage scheduling of production, interfacing with requesters, all purchasing, day-to-day operations.
Oversee and manage Quality Assurance including daily Quality Control Testing of finished drug, Facility maintenance and compliance, training, documentation and inventory control.
Participate in direct microbiological, biochemical, and analytical testing of final drug products.
Must be willing and comfortable handling large amounts of radioactivity and working in radiation environments.
Manage scheduling of production for internally/externally used final drug products. Includes invoicing, maintaining production calendars, interfacing with receiving institutions, and appropriate billing of receiving parties.
Inventory control, purchasing and other administrative tasks needed to run the facility.
Participate in the Quality Control testing of produced radiopharmaceuticals on a daily basis as needed.
Develop, implement, and oversee training programs for synthesis, QA/QC work, operations, and general procedures based on existing and to be written SOPs.
Participate, implement, and monitor regulatory compliance throughout the entire Cyclotron Facility Structure. This includes regulatory filings like INDs and ANDAs with the FDA. Proven knowledge of regulatory practices as evidenced by prior work experience in any setting that is highly regulated and controlled.
General management of staff with the Director/Associate Director.
Writing, proofing, and developing Standard Operating Procedures (SOPs) as necessary.
Performing internal monthly audits of various functional areas of the Facility.
Participate with general lab maintenance, including sanitation.
Familiarization with how the Cyclotron Accelerator works. Basic understanding of the accelerator and its subsystems in order to oversee maintenance and production schedules, running the machine on an intermittent basis.
Provides expertise to researchers on compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Leads the establishment of new laboratories and provides assistance with purchasing new laboratory equipment; ensuring efficient operation of laboratory, including overseeing maintenance and repair of laboratory equipment.
Uses subject matter and best practices knowledge to perform lab and/or research-related duties and tasks. Works independently to assist with project design.
Solves complex problems relating to the administration of projects, including planning new procedures, adapting existing procedures to the needs of the project, and making significant contributions to methodology.
Performs other related work as needed.
Education:Minimum requirements include a college or university degree in related field.
Master’s degree in Chemistry, Pharmacy, Microbiology, Molecular Chemistry, Medicinal Chemistry or similar field exhibiting appropriate skill-set. Regulatory Affairs Certification programs will also be considered.
Ph.D., PharmD, other higher academic certification. Vocational, apprenticeships or other experience in related fields (pharmacy, physics, chemistry etc.) will be considered in lieu of a higher terminal academic degree.
5-7 years’ experience in chemistry, nuclear chemistry, radiochemistry, pharmacy (including retail) or related fields/areas. No one area need contain the 5-7 years, it can be spread over all related areas. Can include post-doctoral research.
Proven knowledge of regulatory compliance covering: general QC procedures, interfacing with end-user/customers, documentation, etc. Experience need not be limited to pharmaceutical or radiopharmaceutical production.
Expertise in training others and/or being trained and certified.
Proven knowledge of regulatory compliance covering: general QC procedures, interfacing with end-user/customers, documentation, etc.
Experience need not be limited to pharmaceutical or radiopharmaceutical production.
Experience in regulatory affairs and compliance, not necessarily in radiopharmaceutical or pharmaceutical production.
Demonstrable advanced experience in Chemistry, Microbiology, Biochemistry, Molecular Biology, or related areas.
Experience in analytical testing methodologies.
Ability to write and develop Standard Operating Procedures. Must be able to follow procedures exactly.
Experience in running complex machinery or working in a complex, busy environment.
Must be able to work flexible (early morning) hours.
General chemistry/biochemistry knowledge and analytical testing methodology.
Must be capable of working alone and working collaboratively in a small group with demonstrated problem-solving capabilities under pressure situation.
Must be able to work in a non-standard working environment with multiple duties that can change daily.
Must be willing to work with radioactivity (but maintaining University Safety standards).
Must be willing to work with chemicals and equipment in a complex environment.
Must have excellent organization, cleanliness, and work habits.
Proven record of working in highly radioactive or highly regulated environments.
Experience working with drug products for human use.
Documented training in complex equipment, environments, or accelerators.
Understanding of Just-In-Time needs and requirements (not limited to radio-pharmaceuticals), able to work in a high-stress environment.
Experience with complex systems.
Experience in working with personnel outside of the Facility, i.e., Plant/Maintenance personnel, external vendors, shippers, etc.
Radiation and radioactivity training is preferred but not required.
Publications record is preferred but not required.
Requires extensive safety training.
Irregular work schedule.
High noise environment.
Exposure to chemical agents.
Requires protective devices.
Must be willing to work with and around (safely) large amounts of radioactivity.
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.
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
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