Formulation Scientist I

UIOWA•Iowa City, IA

1d•Onsite

About The Position

The Formulation Scientist I will report to the Director of Preformulation and Formulation Development and provide support by conducting experiments, investigations, or evaluations. The incumbent will participate in the formulation and process development for small molecule and biotherapeutic agents. This is a laboratory-based position performing formulation and process development activities specifically for therapeutic products from pre-clinical and Ph I clinical trials through late stage, license application and commercialization. This position performs all assigned formulation and analytical chemistry techniques with minimal supervision after the training period. This position will demonstrate a strong desire and ability to learn scientific principles and their cause and effect on scientific outcomes. This position will review other scientist’s protocols, reports, specifications and test methods and will be responsible to efficiently learn to present interpretations. This position will be responsible for preparing data summary presentations, compiling data, and authoring technical reports and regulatory filings associated with their work. Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues performing various functions, serving on multi-disciplinary project teams within UI Pharmaceuticals. About the University of Iowa Pharmaceuticals 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.

Requirements

MS in Pharmaceutics, Chemistry, or Chemical Engineering; or equivalent combination of relevant education and experience.
Minimum 2 years Industry experience in preformulation/formulation development functions preferred or equivalent postgraduate experience to include:
Demonstrated ability to apply scientific principles to preformulation/formulation development of pharmaceutical dosage forms.
Hands on experience with basic analytical techniques such as HPLC, UV-Vis, and other routine lab instruments.
Demonstrated ability to work independently and collaboratively.
Excellent written and oral communication skills.
Demonstrated ability to apply good documentation and record practices.
Candidate should be knowledgeable with scientific investigation and thinking, proactively identify issues, and develop solutions.

Nice To Haves

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 cGMPs, including CMC regulatory information required for INDs/NDAs/ANDAs with respect to API, preformulation, formulation, analytical methods, and dosage form manufacturing processes.
Working knowledge of statistics relevant to pharmaceutical product development.
Knowledge of requirements to safely work with Safebridge 3 compounds.
Skillful at authoring and reviewing technical documents including, standard operating procedures, product development reports, batch records etc.

Responsibilities

Coordinate and implement multiple research projects/programs under the direction of departmental Director.
Perform basic and complex techniques as outlined in research plans, assure fidelity to scientific protocols, assist in design of research plans/protocols.
Experience in lab scale process of drug product formulation and scale-up of formulations through pilot scale.
Collaborate and interact with scientists, chemists, and manufacturing personnel, and plan and execute the generation, characterization, and analysis of pharmaceutical materials.
Collect and interpret experimental 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.
Assure safety and 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.
Ensure compliance with UI policies and procedures.
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).
Coordinate and manage equipment at facility.
Produce written materials in business- and industry-specific technical language related to development of a variety of pharmaceutical products.
Assist with Human Resource functions, including interviewing, selection, training, performance review, 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.

Benefits

Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
exceptional health coverage
university-paid life insurance
robust retirement plans
generous leave policies
24/7 support services
well-being resources
access to UI Health Care specialists
advanced training
leadership development
tuition assistance