This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/11911853 Department
BSD RAD - Cyclotron
About the Department
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.
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.
Job Summary
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.
Responsibilities
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 t sting 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 m