The position will report to the Director of Preformulation and Formulation Development and provide support by conducting experiments, investigations, or evaluations. Collect and analyze data and perform operational duties associated with laboratory or theoretical investigations in preformulation/formulation development for University of Iowa Pharmaceuticals. Qualified candidates may be eligible for an adjunct teaching appointment within the College of Pharmacy, professional and graduate programs. Duties to include:
Research, Experiments, Investigations and Evaluations
Coordinate and implement multiple research projects/programs under the direction of departmental Director.
Perform basic and complex techniques as outlined in research plans, assure fidelity to scientific protocols, and assist in design of research plans/protocols.
Identify and adhere to Quality Assurance practices to maintain validity and integrity of research data.
Collect, Analyze and Summarize Data
Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization and analysis of pharmaceutical materials.
Collect and interpret experimental data to guide subsequent experiments aimed at pharmaceutical product and process development.
Assure safety and compliance with required organization and regulatory policies for laboratory activities, respond to compliance and safety violations.
Responsible for the appearance, function, maintenance, and compliance of the group’s equipment and physical space.
Develop written operating procedures; provide employee training and maintain written documentation of equipment training.
Master’s degree in Pharmaceutics, Chemistry, or Chemical Engineering or equivalent combination of relevant education and experience.
Minimum two (2) years’ industry experience in preformulation/formulation development functions to include:
Demonstrated ability to apply scientific principles to preformulation/formulation development of pharmaceutical dosage forms.
Working knowledge of cGMPs, including CMC regulatory information required for INDs/NDAs/ANDAs with respect to API, preformulation, formulation, analytical methods, and dosage form manufacturing processes.
Knowledge of requirements to safely work with Safebridge 3 compounds.
Demonstrated ability to work collaboratively in diverse environments.
Excellent written and oral communication skills.
PhD in Pharmaceutical Sciences or Chemical Engineering
Expertise in the development of freeze-dried formulations for small molecules and biologicals.
Expertise in addressing solubility and bioavailability issues in the 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.
Working knowledge of statistics relevant to pharmaceutical product development.
Record of publications and presentations describing investigations focused on preformulation/formulation activities.
Demonstrated leadership roles in academic, industrial, or professional organizations.
Internal Number: 20002546
About University of Iowa 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).