We are looking for a Director of Manufactuing Operations to join our team at UI Pharmaceuticals

UI Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) within the College of Pharmacy at the University of Iowa. Our mission is to improve quality of life by applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be the premier partner for biotech, government and research institutions.  

We are located on the main campus in Iowa City, which offers a great place to live, top rated schools, a vibrant night life, and world class health care facilities. As a University of Iowa employee, you will have access to an excellent benefits package.

We are expanding our capabilities while maintaining our culture focused on quality, customer service and community. Consider accelerating your leadership and technical skills by joining us on the next phase of our growth strategy.

About the position:

The Director of Manufacturing Operations is a leadership position within UI Pharmaceuticals reporting directly to the Managing Director. The Director will be responsible for developing and implementing a strategic plan to advance UI Pharmaceuticals injectables and solid oral dosage form manufacturing operations. These responsibilities include advancing technical and operational capabilities and maintaining compliance with cGMPs requirements and safety policies. The Director will also be responsible for recruiting, training, developing, and retaining staff toward the goal of producing high-quality products on time and in full for UI Pharmaceuticals’ clients.

Key Areas of Responsibility

Compliance

• Ensure that the organization adheres to cGMPs and all regulatory agencies (i.e., FDA, EMA, DEA, etc.) guidelines.

• Initiate, implement, and review new policies and programs to comply with regulatory requirements including evolving cGMP practices.

• Organize specific training to ensure the work force can conduct their work responsibilities in accordance with OSHA and cGMPs.

Manufacturing

• Direct and optimize operational activities of the manufacturing units to ensure effectiveness of the operations and a foundational quality culture.

• Provide technical advice and guidance leading to evidence-based approach to problem solving.

• Research new concepts and technologies and develop business cases for expanding capability to keep pace with evolution of pharmaceutical manufacturing.

Leadership

• Develop and implement policies and practices that support staff engagement in the workplace.

• Articulate clear expectations, monitor performance, and provide feedback across areas of responsibility to drive a high-performance organization.

• As a member of the Senior Leadership Team, actively commits to and participates in enterprise-wide strategies, initiatives, and culture development. 

Financial

• Provide operational input to Business Development in developing quotes for manufacturing projects.

• Manage and monitor unit’s productivity to effectively reach its yearly revenue and spending targets.

• Provide input in developing yearly budget and capital plans in alignment with enterprise strategy and department’s needs.

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, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.

Required Qualifications 

Education:

• Professional degree in Pharmacy (PharmD) or master’s degree in chemistry, engineering, or similar fields of study with aseptic processing knowledge.

Experience:

• Minimum of 7 years in federally regulated pharmaceutical manufacturing environment with demonstrated capabilities in:
  • Leading, directing, and scheduling diverse production operations.
  • Qualification or commissioning of facilities or equipment installation.
  • Investigating and troubleshooting atypical events in a production facility.
• Knowledge of cGMP, FDA, EMA, DEA and ICH regulations and guidelines.
• Demonstrated leadership in recruiting, retaining, and developing staff.
• Demonstrated commitment to promoting a diverse, equitable and inclusive environment.

Desirable Qualifications

• Experience in sterile products aseptic production, validation, and Clean Room operations.
• Experience in tablet, capsule, solution, and ointment manufacturing.
• Experience in biotech or contract development and manufacturing organizations (CDMO).
• Experience in preparing, negotiating, and quoting contracts with client organizations.
• Previous P&L or budget management responsibilities.
• Strong communication, problem solving and interpersonal skills.
• Able to work in a fast-paced hands-on environment.