This is a newly created position with shared responsibilities in the Division of Pharmaceutics and Translational Therapeutics (PTT) and University of Iowa Pharmaceuticals (UIP), the UI College of Pharmacy’s fully-funded cGMP contract development and manufacturing organization, has been established to further enhance interactions and the sharing of expertise between the units. The responsibilities associated with this position include: 1) Manage preformulation/formulation development functions for UIP including client recruitment, engagement and outreach, performance and management of formulation development activities, management and fulfillment of contract obligations, and composing technical reports; 2) Teaching in the College of Pharmacy graduate, undergraduate and/or professional programs, including providing mentorship to graduate students; 3) participating in scholarly efforts; and 4) providing additional internal and external service, based on collegiate and university needs and the interests and expertise of the appointee.
This jointly held position will share time commitments between PTT and UIP. The position includes a non-tenure track appointment in the Department of Pharmaceutical Sciences and Experimental Therapeutics (PSET) at The University of Iowa. Depending on background and interest of the appointee it is estimated that effort dedicated to teaching and student instruction would range of from 20% to 50% of total effort. This appointment will be made to the clinical track, and the type of appointment will be determined in collaboration with the PSET Department Chair and the candidate based on the candidate’s qualifications, scholarship and teaching interests, and career goals. The candidate will also be appointed as a Manager of Preformulation for UIP (estimated 50% to 80% of effort with preformulation); the appointment level is dependent on candidate’s specific qualifications in preformulation and previous leadership experiences.
The successful candidate is expected to:
Meet Expectations for Faculty Success in The University of Iowa College of Pharmacy
Deliver instruction to professional, undergraduate, and graduate students.
Mentor graduate students in the Pharmaceutics graduate program. This includes serving as dissertation/thesis committee chair or committee member and additional interactions with students serving as teaching and research assistants.
Contribute to the creation or dissemination of new knowledge through independent and/or collaborative scholarship; publications in scientific literature; and/or attendance and presentation at appropriate scientific or professional conferences.
Provide input and service to university, collegiate, departmental, divisional, and professional committees.
Manage preformulation efforts for the University of Iowa Pharmaceuticals (estimate 50-80%)
Work closely with the UIP Director, Director of Preformulation, and the Senior Leadership Team to achieve the goals of UIP.
Report to the Director of Preformation/Formulation Development and will be expected to manage preformulation/formulation development functions for University of Iowa Pharmaceuticals.
Interact regularly with sponsors/clients to communicate estimated material requirements, timing of planned activities, outcome of tasks performed, proposals for future work, and milestone achievements.
Build rapport with clients to achieve a high level of customer satisfaction with organizational products, services, and expertise.
Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization and analysis of pharmaceutical materials.
Develop written operating procedures; provide employee training and maintain written documentation of equipment training.
Lead projects and personnel to facilitate smooth and methodical progression of projects.
Collect experimental data and evaluate relevance of data. Interpret collected data to guide subsequent experiments aimed at pharmaceutical product and process development.
Develop formulations and processes suitable for manufacturing clinical trial supplies, in cooperation with internal manufacturing and analytical research groups.
Ensure compliance with required organization and regulatory policies for laboratory activities.
Responsible for the appearance, function, maintenance, and compliance of the group’s equipment and physical space; identify equipment for purchase; qualify equipment for use.
Collaborate and interact with collegiate faculty, particularly in the division of Pharmaceutics and Translational Therapeutics (PTT) to advance research and development projects within University of Iowa Development Consortium (UIPDC).
PhD degree in Pharmaceutics, Chemistry, or Chemical Engineering or similar fields with 3 years of industry experience in preformulation/formulation development functions
Demonstrated ability to apply scientific principles to preformulation/formulation development of pharmaceutical dosage forms.
Demonstrated experience in independently leading pharmaceutical product development activities.
Working knowledge of cGMPs, including working knowledge of CMC regulatory information required for INDs/NDAs/ANDAs with respect to API, preformulation, formulation, analytical methods, and dosage form manufacturing processes.
Working knowledge of statistics relevant to pharmaceutical product development.
Knowledge of requirements to safely work with hormones and potent, cytotoxic compounds.
Demonstrated ability to work collaboratively in diverse environments.
Excellent written and oral communication skills.
Expertise in development of freeze-dried formulations for small molecules and biologicals.
Expertise in addressing solubility and bioavailability issues in development for oral or parenteral pharmaceutical products.
Expertise in characterization of pharmaceutical materials and an understanding of material properties and their influence on product quality.
Record of publications and presentations describing investigations focused on preformulation/formulation activities.
Demonstrated leadership roles in academic, industrial, or professional organizations.
Record of successful teaching of pharmacy, undergraduate, and/or graduate students.
Additional Salary Information: University of Iowa offers an excellent benefits package.
Internal Number: 73698
About U of Iowa College of Pharmacy Department of PTT and UI Pharmaceuticals
The University of Iowa Pharmaceuticals (UIP), a service division of the College of Pharmacy, is a Food and Drug Administration (FDA) registered and Drug Enforcement Administration (DEA) licensed pharmaceutical manufacturing facility. UIP offers contract services for pharmaceutical development, manufacturing, and analytical testing. Established in 1974, this division specializes in parenteral, solid, liquid and topical dosage formulations, clinical supplies and commercial manufacturing services as well as analytical services in compliance with current Good Manufacturing Practices (cGMP).