University of Iowa Pharmaceuticals (UIP) is an FDA registered contract manufacturing facility for parenteral and various non-sterile dosage forms. They are seeking a Manufacturing Manager-Sterile Products to lead all aspects of operations for a sterile product production facility while maintaining compliance with current Good Manufacturing Practices (cGMP). Duties to include:
Ensure facilities, equipment and staff meet all regulatory requirements and guidelines set by FDA, DEA or other governing bodies. Ensure a safe manufacturing environment. Ensure the operations follow University recommendations and policies.
Coordinate activities for the manufacture of pharmaceutical clinical or commercial supplies. Implement new procedures as needed. Provide input on the selection, purchase, installation and validation of new pharmaceutical processing equipment and the associated documentation. Review and analyze data and recommend improvements for manufacturing processes.
Design, evaluate and coordinate training of employees on new equipment and processes.
Develop budget and staffing plans based on current and future workload projections. Responsible for effective use of resources and fiscally responsible decisions making.
Perform human resource functions including interviewing, selection, training, performance review, salary determination, promotion and disciplinary action.
For a full job description, please send an e-mail to the contact listed below.
About University of Iowa Pharmaceuticals (UIP):
University of Iowa Pharmaceuticals is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expertise in contract pharmaceutical development services to clients around the world. This is an exciting time to join UIP, as the business continues to grow in capabilities, new clients and revenue. In 2020 the College of Pharmacy will be moving into a new $96.3 million College of Pharmacy building. The lower level of this new building will be home to the UIP new sterile products manufacturing area which will be approximately 16,000 square feet and will increase UIP batch size capacity approximately 5-fold to 20,000 vials/batch.
A Bachelor's degree preferably in Pharmacy, Pharmaceutical Sciences, Engineering, Business or a natural science (such as Biology, Chemistry, Microbiology).
Minimum 5 years' experience in a sterile production facility, to include both processing and administrative supervision of staff, in an environment that follows current Good Manufacturing Processes (cGMP) under the guidance of other regulatory bodies such as, the Food and Drug Administration.
Demonstrated experience performing one or more of the following:
Composed, edited and adhered to Standard Operating Procedures.
Maintained internal controls such as, documentation and processing controls to ensure compliance.
Planned, organized, monitored, and controlled projects.
Applied principals related to pharmaceutical preparation and practices.
Strong written and verbal communication skills.
Processed information with high levels of accuracy and attention to detail.
Project management experience of sterile products in a current Good Manufacturing Practice pharmaceutical manufacturing environment.
Ability to ensure safe practices in daily operations and effective maintenance and repair services for physical premises.
Ability to implement HSE policies to ensure that provided products and services are safe for people and the environment and in compliance with legal requirements and standards.
Application Details: In order to be considered for an interview, applicants must upload a resume and cover letter and mark them as a "Relevant File" to the submission. Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be subject to a criminal background check and credential check. Up to 5 professional references will be requested at a later step in the recruitment process.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 21002402_1620741744
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.