Director, Drug Product Development & Formulation

Lipocine Inc.; Salt Lake City (UT); Hybrid; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

Lipocine Inc. in Salt Lake City, Utah, is seeking an Associate Director/Director, Product Development to lead the drug product development team across programs, from formulation to manufacturing.

This full-time role offers growth opportunities and a competitive compensation package. The position requires PhD or MS in pharmaceutical sciences/chemistry/chemical engineering with industry experience (5+ years with PhD or 8+ years with MS).

Qualifikationen

• PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related field with industry experience in drug product development (5+ years with PhD or 8+ years with MS).
• Direct, hands-on experience in formulation development and manufacturing of solid and liquid oral dosage forms.
• Working knowledge of chemical and physical properties of APIs and excipients in relation to drug product development.
• Thorough understanding of current formulation technology platforms and analytical characterization techniques, including DSC, XRPD, microscopy, HPLC, Dissolution, LOD, Density tester, Friability tester etc.
• Prior experience with CROs/CMOs is highly desirable.
• Excellent communication skills, problem solving, critical thinking, team and organization skills.

Aufgaben

• Lead the drug product development team for assigned programs.
• Conduct activities related to formulation development under research and development settings
• Carry out pre-formulation required for the assessment of developability of an API, including solution and solid-state characterization studies, solubility/solubility enhancement studies, compatibility studies, polymorph and salt screening and characterization, particle size analysis, assessment of bulk properties of powders etc.
• Design and execute detailed experiments developing formulation and manufacturing process under QbD principles and transferring these methods and processes to drug product manufacturers.
• Lead the design, development and manufacturing of preclinical formulations and early clinical supplies.
• Oversee and troubleshoot various developmental and manufacturing activities at CMOs.
• Author/review manufacturing batch records, SOPs, technical reports such as formulation development report and other relevant scientific information packages for internal use or agency submissions.
• Critically assess experimental data and provide interpretation of results.
• Establish work schedules to ensure timely completion of the required activities.
• Work collaboratively with analytical R&D, pre-clinical, and clinical teams.
• Other relevant duties as assigned.

Kenntnisse

Communication

Problem solving

Teamwork

Organization

Ausbildung

PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related

Jobbeschreibung

Lipocine Inc. in Salt Lake City, Utah, is seeking an Associate Director/Director, Product Development to lead the drug product development team across programs, from formulation to manufacturing.

This full-time role offers growth opportunities and a competitive compensation package. The position requires PhD or MS in pharmaceutical sciences/chemistry/chemical engineering with industry experience (5+ years with PhD or 8+ years with MS).