Senior Scientist

Company: The University of Iowa
Location: Waterloo
Posted on: January 25, 2023

Job Description:

UI Pharmaceuticals is seeking a Senior Scientist to join their team. The position will conduct experiments, investigations, 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 late stage, license application and commercialization. This position 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 ResponsibilityResearch, Experiments, Investigations and EvaluationsFunction 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 DataContribute 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.ComplianceEnsure 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 ManagementPerform 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.SupervisionDevelop 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.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 libby-kleppe@uiowa.eduRequired QualificationsEducation:Master's degree in Pharmaceutics, Chemistry, Biochemistry or Chemical Engineering; or equivalent combination of relevant education and experience.Experience: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 sterile pharmaceutical dosage forms.Demonstrated experience in independently leading pharmaceutical product development activities, within the industry.Extensive knowledge applying analytical techniques such as HPLC/UPLC, UV-Vis, DSC, PXRD, and other routine lab instruments.Knowledge of requirements to safely work with hormones and potent, cytotoxic compounds.Demonstrated ability to plan and work independently, coach/ guide junior scientists, work collaboratively with cross-functional teams and in diverse environments.Desirable QualificationsExpertise in the development of freeze-dried formulations for small molecules and biologicals.Expertise in addressing solubility and bioavailability issues in the development for oral and parenteral pharmaceutical products.Demonstrated ability for critical-thinking and problem-solving skills with working knowledge of cGMPs, Quality by Design (QbD) principles and CMC regulatory knowledge required for INDs/NDAs/ANDAs with respect to API, formulation, analytical methods, and manufacturing processes.Expertise in characterization of pharmaceutical materials and an understanding of material properties and their influence on product quality.Skillful at authoring and reviewing technical documents including, standard operating procedures, product development reports, batch records etc.Application and Position DetailsIn order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:ResumeCover LetterJob 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.Benefits HighlightsRegular 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? Click here.

Keywords: The University of Iowa, Waterloo , Senior Scientist, Other , Waterloo, Iowa