Formulation Scientist I

About the role

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.

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, analyze and summarize data.
• Develop formulations and processes suitable for manufacturing clinical trial supplies, in cooperation with internal manufacturing and analytical research groups.
• Affirm 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.
• 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.

Qualifications

• Education: MS in Pharmaceutics, Chemistry, or Chemical Engineering; or equivalent combination of relevant education and experience.
• 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.
• 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 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.