Preformulation and Formulation Development Manager

The University of Iowa

Job Reference #: 20003254

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 Manager will include: client engagement and outreach, performance and management of formulation development activities, management and fulfillment of contract obligations, and composing technical reports.

Analysis and Development
• Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization and analysis of pharmaceutical materials.
• Collect experimental data and evaluate relevance of data. Interpret collected data to guide subsequent experiments aimed at pharmaceutical product and process development.
• Develop formulations and processes suitable for manufacturing clinical trial supplies, in co- operation with internal manufacturing and analytical research groups.

Compliance
• Ensure compliance with required organization and regulatory policies for laboratory activities.
• Responsible for the appearance, function, maintenance, and compliance of the group’s equipment and physical space; identify equipment for purchase; qualify equipment for use.
• Develop written operating procedures; provide employee training and maintain written documentation of equipment training.
• Review and approve all test results, reports and stability summaries to ensure accuracy and compliance with protocols and various regulatory requirements.

Leadership
• Lead projects and personnel to facilitate smooth and methodical progression of projects.
• Interact regularly with sponsors to communicate estimated material requirements, timing of planned activities, outcome of tasks performed, proposals for future work, and milestone achievements.
• Build rapport with clients to achieve a high level of customer satisfaction with organizational products, services and expertise.
• Collaborate and interact with collegiate faculty, particularly in the division of Pharmaceutics and Translational Therapeutics (PTT) to advance research and development projects within University of Iowa Development Consortium (UIPDC).

Human Resources
• Assist with Human Resource functions, including interviewing, selection, training, performance review, salary determination, promotion and disciplinary action.
• Design, evaluate, and coordinate training of employees on techniques and procedures needed to execute development projects.
• Provide and maintain written documentation of employee training, as required.
• Conduct and/or provide input in quarterly staff performance reviews.

Financial Responsibility
• Assist in budget development and provide projections and recommendations.
• Develop and implement organizational goals including revenue generation targets, in collaboration with director.
• Engage with existing and potential clients; respond to requests for work proposals, produce work proposals and quotes to seek contracts for UIP and UIPDC, and produce monthly client invoices.

REQUIRED QUALIFICATIONS

Education:
Master’s degree in Pharmaceutics, Chemistry, or Chemical Engineering; a combination of equivalent education and experience may fulfill the educational requirement.

Experience:
Minimum three (3) 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 hormones and potent, cytot oxic compounds.
• 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.
• Working knowledge of statistics relevant to pharmaceutical product development.

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.

For more information about the College of Pharmacy, please visit https://pharm acy.uiowa.edu/about-college.

 

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: 71696

Posted 5 days ago

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