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 nightlife, and world-class healthcare 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 in the next phase of our growth strategy.
The Senior Scientist will conduct experiments, investigations, and evaluations, providing technical guidance to peers/chemists. The incumbent will participate in the formulation and process development for small molecule and biotherapeutic agents. This is a laboratory-based technical specialist position contributing to formulation and process development activities specifically for therapeutic products from pre-clinical and Ph III clinical trials through the late stage, license application, and commercialization.
The Senior Scientist performs all assigned formulation and analytical chemistry techniques independently and works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity. This position will be responsible for preparing data summary presentations, compiling data, and authoring technical reports and regulatory filings associated with their work. This position will participate in coaching, mentoring, and guiding other scientists in conducting experiments and developing various complex dosage forms.
Key Areas of Responsibility
Research, Experiments, Investigations and Evaluations
Function as a specialist/ technical expert for the analytical, formulation and process development activities and develop sterile and non-sterile dosage forms.
Apply technical proficiency, scientific rationale with regulatory knowledge, collaboration with others and independent thought in developing experimental design and strategy.
Investigate and perform critical analysis of existing methodologies; Collaborate with manufacturing operations and analytical services in trouble shooting product or process issues. Solve complex formulation issues either independently or in collaboration with others.
Apply knowledge to understand the physical and chemical characterization of molecules, including solid-state and solution properties.
Collect, Analyze and Summarize Data
Contribute at a high level to the lab/research project(s) providing technical assistance.
May independently author product development reports, job-aids, standard operating procedures, and risk-assessment documents.
Develop new methodology and techniques related to sterile and non-sterile development projects.
Perform statistical analysis of data using advanced statistical methods and tools.
Ensure safety and compliance with required organization and regulatory policies for laboratory activities, respond to compliance and safety violations.
Ensure compliance with UI policies and procedures.
Responsible for the operation, performance, maintenance, and compliance of the laboratory equipment and physical space; identify equipment for purchase; qualify equipment for use.
Develop written operating procedures; provide group and cross-departmental trainings and maintain written documentation of equipment training.
Administrative and Project Management
Perform administrative functions, including but not limited to writing and amending study plans, protocols, to make/influence decisions with acquisition of equipment, software, and supplies.
Ensure safety of the employees, help with safety audits/ safety programs.
Communicate directly with any external stakeholders (funders, partners, etc.) as to progress the projects, reporting requirements and milestones.
Produce written materials in business- and industry-specific technical language related to development of diverse pharmaceutical products.
Develop training procedures for basic and high-level lab techniques and protocols.
Assist with Human Resource functions, including interviewing, selection, training, may provide input in annual staff performance reviews.
Design, evaluate, and coordinate training of employees on basic and new laboratory techniques and procedures needed to execute development projects.
About UI Pharmaceuticals - University of Iowa College of Pharmacy
University of Iowa Pharmaceuticals (UI Pharmaceuticals) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States. UI Pharmaceuticals has been developing formulations, manufacturing products, and conducting analytical testing in compliance with cGMPs for almost 45 years. During the past 5 years UI Pharmaceuticals has manufactured over 1100 batches of product for over 100 different sponsors. UI Pharmaceuticals serves a broad spectrum of clients of all sizes in the pharmaceutical and biotechnology industries and has performed work for pharmaceutical companies throughout the United States and the world. Additionally, UI Pharmaceuticals has performed work for numerous government agencies, including the National Cancer Institute, the Centers for Disease Control, and the National Institutes of Health. UI Pharmaceuticals is capable of producing most types of pharmaceutical dosage forms. These dosage forms include sterile injectable solutions; sterile lyophilized (freeze-dried) powders; topical and oral solutions, emulsions, and suspensions; tablets (uncoated and film or functional coated); and hard gelatin capsules ...(powder or hot melt filled). UI Pharmaceuticals is compliant with 21 CFR parts 11, 210, and 211, licensed by the Drug Enforcement Agency (DEA) to handle controlled substances (Schedules I - V) and capable of handling potent/cytotoxic materials. UI Pharmaceuticals has produced numerous products for use in the European Union (EU) and passed numerous Qualified Person (QP) audits.