Director Of Manufacturing Operations

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

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

Manufacturing

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

Leadership

• As a member of the Senior Leadership Team, actively commits to and participates in enterprise-wide strategies, initiatives, and culture development.
• Articulate clear expectations, monitor performance, and provide feedback across areas of responsibility to drive a high-performance organization.
• Develop and implement policies and practices that support staff engagement in the workplace.

Financial

• Manage and monitor unit's productivity to effectively reach its yearly revenue and spending targets.
• Provide operational input to Business Development in developing quotes for manufacturing projects.
• Provide input in developing yearly budget and capital plans in alignment with enterprise strategy and department's needs.

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.
For a complete job description, please contact Libby Kleppe at [email protected]
Education
Required Qualifications

• Bachelor's degree in chemistry, engineering, biology, pharmacy, or a related science.

Experience

• Knowledge of cGMP, FDA, EMA, DEA, and ICH regulations and guidelines.
• Demonstrated commitment to promoting a diverse, equitable, and inclusive environment.
• Aseptic processing in a manufacturing environment.
• Investigating and troubleshooting atypical events in a production facility.
• Qualification or commissioning of facilities or equipment installation.
• Leading, directing, and scheduling diverse production operations.
• Minimum of 7 years with a master's degree or 10 years in a federally regulated pharmaceutical manufacturing environment with demonstrated capabilities in:
• Demonstrated leadership in recruiting, retaining, and developing staff.

Highly Desirable Qualifications

• Professional Degree in Pharmacy (PharmD).

Desirable Qualifications

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

Application and Position Details

• Cover Letter
• Resume
• Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact Libby Kleppe at [email protected].
• In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:

Benefits Highlights

• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
• For more information about Why Iowa? Click here.
• Regular salaried position. Located in Iowa City, Iowa.

Additional Information

• Appointment Type: Professional and Scientific
• Classification Title: Manufacturing Director
• Schedule: Full-time

Compensation

• Pay Level: 6B
• Starting Salary Maximum: commensurate
• Starting Salary Minimum: 120,000

Contact Information

• Contact Email: [email protected]
• Organization: College of Pharmacy
• Contact Name: Libby Kleppe

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.