Director of Sterile Products Manufacturing

The University of Iowa

Job Reference #: 22003536

The Director of Sterile Products Manufacturing 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 sterile products capability. These responsibilities include advancing operational capabilities, recruiting, training, and retaining staff and guiding the workforce in 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 unit 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 sterile product 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 participate in enterprise-wide strategies, initiatives, and culture development.

Financial

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

For a complete job description, please contact Libby Kleppe at libby-kleppe@uiowa.edu

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:
    • Sterile products aseptic production, validation and Clean Room operations.
    • Process qualification and validation of pharmaceutical product lyophilization.
    • Qualification or commissioning of facilities or equipment installation.
  • Knowledge of cGMP, FDA, EMA, DEA and ICH regulations and guidelines.
  • Experience in working in a production or manufacturing environment.
  • Demonstrated leadership in recruiting, retaining, and developing staff.
  • Demonstrated commitment to promoting a diverse, equitable and inclusive environment.

Desirable Qualifications

  • 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.

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.

Job Benefits:

Benefits Highlights

  • Regular salaried position. Located in Iowa City, Iowa.
  • 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? Go to worklife.uiowa.edu/

Application Instructions:

Application and Position Details

  • In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
    • Resume
    • Cover Letter
  • 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 subject to a criminal background and credential check. 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact Libby Kleppe at libby-kleppe@uiowa.edu.

Job ID: 81671

Posted 11 days ago

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