Scientist/Senior Scientist of Liquid Formulation Development
We are seeking a Scientist/Senior Scientist of Liquid Formulation Development for our Overland Park campus. In this role, the successful candidate will be the subject matter expert in oral liquid formulations, and provide scientific solutions and strategic guidance as part of a multi-discipline product development team in support of 505(b)2 development programs and pharmacy convenience kits. He/she will be responsible for the hands-on development of powder/diluent, and drug solution/suspension formulations, from laboratory prototypes to final formulation selection, scaleup and transfer to internal manufacturing groups or CDMOs. The work is highly collaborative and requires excellent communication skills and a desire to be part of a team.
DUTIES & RESPONSIBLITIES
Develop powder/diluent, and drug solution/suspension formulations from scientific understanding of the relevant physical and chemical properties of the diluent, drug, and excipients.
Provide technical/scientific support associated with the Company’s NDA/505(b)(2) pathway pipeline programs.
Reformulate and/or improve existing product formulations when needed.
Author scientific papers and study reports, including product development reports.
Support intellectual property development as needed.
Provide technical guidance to CDMOs and resolve development issues during manufacturing scaleup and validation.
Provide support for CMC section of regulatory submissions.
In-depth understanding of physicochemical fundamentals of formulation development.
M.S. with 5 years or Ph.D. with 2 or more years of relevant oral liquid formulation research & development experience in the pharmaceutical industry. New PhD graduates with a strong background in pharmaceutical chemistry or pharmaceutics will be considered.
Experience supporting drug product development focused on small molecule programs.
Demonstrated ability to analyze and interpret data.
Understanding of regulatory guidance documents (ICH, USP, BP, EP, JP, FDA, EMEA) a plus.
Experience in planning, managing activities and trouble-shooting development issues at CDMOs.
Ability to organize, prioritize and deliver tasks and projects with a sense of urgency under minimal supervision without neglecting attention to detail.
Good interpersonal communication skills/ability to work in a team environment.
Excellent organizational, verbal and written communication skills.
CMC Regulatory Writing/Review experiences a plus.
Must be able to travel upon occasion to vendor and contract manufacturer sites.
Must be authorized to work in the United States for any employer without the need for sponsorship
About Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately-held specialty pharmaceutical company formed by the acquisition of Silvergate Pharmaceuticals, Inc. by CutisPharma, Inc., in May 2019. Azurity focuses on the needs of patients, especially children and the elderly, requiring customized, user-friendly drug formulations. Azurity’s products, including Epaned® (enalapril maleate) Oral Solution, Qbrelis® (lisinopril) Oral Solution, Xatmep® (methotrexate) Oral Solution, FIRVANQ® (vancomycin hydrochloride) for oral solution, and FIRST® Unit-of-Use Compounding Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by other commercially available therapies. For more information, visit www.azurity.com.