The University of Iowa Pharmaceuticals (UIP), a division of the College of Pharmacy, seeks qualified applicants for a full-time Preformulation and Formulation Development Manager. This position will report to the Managing Director and will direct and perform preformulation/formulaion development functions. Areas of focus include client engagement and outreach, performance and management of formulation development activities, management and fulfillment of contract obligations, and composing technical reports. Qualified candidates may be eligible for an adjunct teaching appointment within the College of Pharmacy undergraduate, professional and graduate programs.
Duties and responsibilities include:
• Develop formulations and processes suitable for manufacturing clinical trial supplies, in cooperation with internal manufacturing and analytical research groups. • Collect and interpret experimental data to guide subsequent experiments aimed at pharmaceutical product and process development. • Coordinate and manage multiple preclinical research projects/programs. • Conduct complex research and direct all phases of the project/program/service. • Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization and analysis of pharmaceutical materials. • 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). • Design, evaluate, and coordinate training of employees on techniques and procedures needed to execute development projects. • Engage with existing and potential clients; respond to requests for work proposals, produce work proposals and quotes to seek contracts for UIP and UIPDC, and produce monthly client invoices. • Ensure compliance with required regulatory policies, ensure staff compliance with policies and procedures. • May perform other duties as assigned.
Master’s degree in Pharmaceutics, Chemistry, or Chemical Engineering or equivalent combination of relevant education and experience.
Minimum three (3) years’ industry experience in preformulation/formulation development functions to include:
Demonstrated ability to apply scientific principles to preformulation/formulation development of pharmaceutical dosage forms.
Demonstrated experience within industry independently leading pharmaceutical product development activities.
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.
Valid driver's license and the ability to meet the University of Iowa's Fleet Safety requirements.
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.
Record of successful teaching of pharmacy to undergraduate, professional and/or graduate students.
Internal Number: 19004164
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).