The University of Iowa Pharmaceuticals is a Food and Drug Administration (FDA) registered contract manufacturing facility of both parenteral and non-sterile dosage forms. The primary responsibilities of this position are to plan, direct, and coordinate manufacturing of sterile projects for client pharmaceutical and biotechnology organizations. A key component includes a strong commitment to product quality.
Key Areas of Responsibility
Oversee client projects, assuring the facilities and equipment are operational and staff is adequate and trained in accordance with Federal Drug Administration (FDA) Drug Enforcement Administration (DEA) or other governing bodies. Evaluate the safety profiles of new or existing chemical entities and provide safety policies and proper handling of hazardous materials and hazardous waste. Assure the operations follow University recommendations and policies. * Develop quality assurance processes according to current Good Manufacturing Practices (cGMP). * Monitor production records for compliance with regulatory guidelines. * Arrange training of staff to meet client projects and cGMP guidelines.
Collaborate with clients to develop a workable formulation through discussions, providing technical consultative services, or by the manufacture of small-scale development activities to better assure a successful large-scale production batch. 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. * Collaborate with project managers and assistant directors to schedule and plan production or quality control activities utilizing Good Manufacturing Practices (GMP). * Aid the manufacturing director with renovation of areas, equipment, and processes. * Communicate with clients and define responsibilities and processes for production or quality control projects. * Research equipment purchases and make recommendations. * Resolve operational problems. * Coordinate equipment schedules. * Advise manufacturing director of equipment needs and operational problems.
Design, evaluate and coordinate training of employees on new equipment and processes needed to complete client projects. * Demonstrate leadership by aligning, influencing, and inspiring staff to produce the change needed to meet the direction of UIP goals.
Perform human resource functions including interviewing, selection, training, performance review, salary determination, promotion, and disciplinary action. * Develop and implement job standards; hold staff accountable for departmental and divisional goals. * Assist production staff with definition and solution of problems. * Perform the following functions including interviewing, selection, training, performance evaluation, salary determination, promotion and disciplinary action.
Assist in budget development and provide projections and recommendations. * Assist in the development of plans and budgets for laboratory and production areas. * Develop quotes for client projects.
For a complete job description including all Key Areas of Responsibility and Universal and Technical Competencies, please send an email to firstname.lastname@example.org.
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, Pharm.D., Business, or other natural scientific discipline (such as Biology, Chemistry, Microbiology) and at least two years' experience in a current Good Manufacturing Practices (cGMP) or similar manufacturing environment.
Experience or knowledge performing one or more of the following: * Pharmaceutical Research, Development and Manufacturing * Product Design and Development * Standard Operating Procedures * Internal Controls * Performance Management * Project Management
Experience or knowledge of: * Premises Operation and Maintenance * Health, Safety and Environment Policy Compliance * Developing or reviewing Quotes
Experience working in a Sterile production environment regulated by Food and Drug Administration (FDA) current Good Manufacturing Processes (cGMP) or equivalent regulations.
Project management experience of sterile products in a current Good Manufacturing Practice (cGMP) pharmaceutical manufacturing environment.
In order to be considered for an interview, applicants must upload a submission-specific 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. This job may be removed from posting and filled any time after the minimum posting period has ended. Successful candidates will be subject to a criminal background and credential check. 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: 21002555_1621444118
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.