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 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
Apply various technologies to enhance poorly soluble drug candidates and in related physical and chemical characterization
Perform standard analytical techniques including HPLC/UPLC, UV, DSC, Water Content Determination using Karl Fisher
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
Perform qualitative data analysis and data interpretation to guide subsequent experiments aimed at pharmaceutical product and process Present data and project updates to internal parties and to stakeholders
Collaborate and interact with scientists, chemists and manufacturing personnel, plan and execute the generation, characterization, and analysis of pharmaceutical materials
Develop formulations and processes suitable for manufacturing clinical trial supplies, in co- operation with internal manufacturing and analytical research groups
May develop new methodology and techniques related to the area of research
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
Use various techniques for information dissemination and information gathering. Advise others on the incorporation of tables, charts, and diagrams into documents
Review the written materials of others and provide feedback and coaching
Build rapport with clients to achieve a high level of customer satisfaction with organizational products, services, and expertise
Effectively prioritize and manage multiple projects and tasks
Listen effectively and actively to invites response and discussion
Communicates in an open, clear, complete, timely, and consistent manner
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
Ability to work with a variety of individuals and groups in a constructive and civil manner and utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs.
Service Excellence/Customer Focus (Extensive)
Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner. Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.
Diversity, Equity, and Inclusion (Extensive)
Ability to work with individuals and groups in a constructive and respectful manner while appreciating the unique contribution of an inclusive workforce that brings together the talents of people across multiple identities (race, creed, color, religion, national origins, age, sex, pregnancy, disability, veteran status, sexual orientation, gender identity, or associational preferences).
Research and Analysis (Expert/Leader)
Analyze published research reports and their possible implications
Interpret new findings and analyze their validity
Implement research analysis standards within the organization and control the quality of research analysis
Advise on advanced research analysis methods
Evaluate research analysis best practices within the industry
Laboratory Testing (Expert/Leader)
Conduct sample collection and preparation for laboratory testing consistent with project needs or standard operating procedures
Knowledge of drug development processes for progression of a biological candidate
Experience with analytical methods such as UV, HPLC/UPLC, DSC etc.
Train others on the appropriate operation of laboratory equipment; address safety issues
Evaluate the accuracy of results obtained from laboratory tests
Recommend solutions to improve existing procedures of laboratory tests
Comply with relevant policy, regulatory and ethics for all laboratory tests
Written/Research Documentation (Expert/Leader)
Designs, writes, and publishes numerous research documents on diverse topics
Determines which types of graphs and charts to use to best communicate research findings
Edits and revises research documents written by others
Guides others on the proper method for citing, footnoting, and documenting other researchers' work
Evaluates procedural differences between hardcopy publishing versus web publishing documentation
Facilitates implementation of websites designed to contain published research
Research Safety (Expert/Leader)
Ensure that all first-aid equipment is operational, and supplies are current and fully stocked
Participate in internal and external safety or health inspections
Follow established safety guidelines in research procedures to prevent illness or injury to self or others
Seek and identify potential or actual safety hazards in storage, handling, transportation, and usage of various hazardous materials
Maintain health and safety records according to organizational and regulatory guidelines
Life at Iowa
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, including paid vacation, sick leave, health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
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.
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, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.
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 firstname.lastname@example.org. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
Master’s degree in Pharmaceutics, Chemistry, Biochemistry or Chemical Engineering or equivalent combination of relevant education and 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
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 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.
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 email@example.com.
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.