Formulation Development Leader, R&D

Job Description

Primary Responsibilities

• 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.

Qualifications

• PhD or MS in pharmaceutical sciences/chemistry/chemical engineering/related scientific discipline with industry experience in drug product development (5+ years with PhD or 8+ years with MS) preferred.
• Direct, hands-on experience in formulation development and manufacturing of solid and liquid oral dosage forms is required.
• Working knowledge of chemical and physical properties of APIs and excipients in relation to drug product development, process and drug delivery.
• Thorough understanding of current formulation technology platforms and analytical characterization techniques, including but not limited to 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.