Preformulation and Formulation Development Director
University of Iowa
Location: Iowa City, Iowa
Type: Full Time
Internal Number: 21003703
University of Iowa Pharmaceuticals (UIP) in the College of Pharmacy at the University of Iowa is seeking a Preformulation and Formulation Development Director. This position will report to the Director of Analytical Services and will be expected to direct and perform preformulation/formulation development functions.
Primary responsibilities for the Preformulation and Formulation Development (PFD) Director will include client engagement and outreach, experimental design, performance and management of formulation development staff and 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.
Key Areas of Responsibility
Analysis and Development • Establish and direct multiple research and development projects/programs to fulfill client service agreements. • Direct all phases of the project and client services. • Collaborate with peer scientists, chemists and manufacturing personnel, in characterization and analysis of pharmaceutical materials.
Compliance • Ensure 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. • Responsible for staff compliance with UI policies and procedures.
Leadership • Build capability and direct the preformulation and formulation laboratory. • Lead the operational, fiscal (capital and budget) and HR/staffing activities for PFD department. • Interact regularly with sponsors to communicate estimated material requirements, timing of planned activities, outcome of tasks performed, proposals for future work, and milestone achievements.
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. • Design and evaluate training techniques and procedures needed to execute development projects.
Financial Responsibility • Oversee the planning and preparation of budgets and capital plan for PFD department. • Perform cost analysis and set prices for activities in PFD department. • Develop and implement organizational goals including revenue generation targets, in collaboration with the Director of Analytical Services and Managing Director.
Please apply through JOBS@UIOWA: http://p.rfer.us/UIOWAMX08ob
Equal opportunity/affirmative action employer
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.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or email@example.com. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
Doctorate degree in Pharmaceutics, Chemistry, or Chemical Engineering or equivalent combination of relevant education and experience.
Experience Required Minimum five (5) years’ industry experience in preformulation/formulation development functions to include: • Demonstrated ability to apply scientific principles to preformulation/formulation development of clinic ready sterile and/or non-sterile pharmaceutical dosage forms. • Demonstrated experience within industry leading pharmaceutical product development activities for use in clinical trials. • 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 or equivalent. • Demonstrated ability to work collaboratively in diverse environments. • Excellent written and oral communication skills.
Experience Desired • 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. • Competency in developing analytical methods to assess product stability • Working knowledge of statistics relevant to pharmaceutical product development. • Demonstrated leadership roles in academic, industrial, or professional organizations.
UI Pharmaceuticals is a fee for service business on the University of Iowa Campus that provides contract drug manufacturing (CDMO) services to academic, biotech, and pharmaceuticals clients. These services range from early-stage formulation development, analytical method support, clinical trial material manufacturing, to commercial product manufacture and support.