Preformulation and Formulation Development Director

The University of Iowa

Iowa City, IA Scientific / Administrative & Clerical

Job Reference #: 20001516

The position will report to the Managing Director and will be expected to direct and perform preformulation/formulation development functions for University of Iowa Pharmaceuticals. Primary responsibilities for the Preformulation and Formulation Development Director will 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 to include:

Analysis and Development

  • Manage research projects, support and conduct complex research, and direct all phases of the project and client services.
  • Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization and analysis of pharmaceutical materials.

Compliance

  • 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.

Leadership

  • Build capability and direct the preformulation and formulation laboratory.
  • Direct complex processes, external relationship development, and project leader ship.
  • Lead projects and personnel to facilitate smooth and methodical progression of projects.

Human Resources

  • Collaborate with human resources personnel to hire new staff.
  • Lead Human Resource functions, including interviewing, selection, training, performance review, salary determination, promotion and disciplinary action, conduct and/or provide input in annual staff performance reviews.

Financial Responsibility

  • Oversee the planning and preparation of budgets. Perform cost analysis and set prices.
  • Develop and implement organizational goals including revenue generation targets, in collaboration with the Managing Director.

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.

Required Education:

  • Doctorate degree in Pharmaceutics, Chemistry, or Chemical Engineering or equivalent combination of relevant education and experience.

Required Experience:

  • Minimum five (5) 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 compound s or equivalent.
  • Demonstrated ability to work collaboratively in diverse environments.
  • Excellent written and oral communication skills.

Desirable Qualifications:

  • 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.
  • Expertise in developing analytical methods to assess product stability
  • 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.

Application Details:

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.

Application Instructions:

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 ID: 70536

Posted 7 days ago

Share This Job