• Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes.
• Evaluation and selection of active, inactive raw materials and packaging components for various products.
• Formulate laboratory test batches to support product development, regulatory submissions and analytical method validation program.
• Development of CPPs, QTTPs, CQAs, and scale up manufacturing processes.
• Preparation of various study protocols to conduct in-compatibility/ compatibility studies including product contact studies with container closure system(s).
• Perform technology transfer of developed processes and procedures to scale up activities.
• Participate in activities leading to Technical Transfer, process validation and commercial production troubleshooting.
• Clearly document all data generated and report all research work performed - includes creation and documentation of study and experimental protocol, development of experimental process, identification and corrections of developmental and manufacturing issues/problems/ observations and writing formulation development report (PDR) based on Quality by Design (QbD) guidelines.
• Prepare GMP documents for Exhibit Batches including technology transfer report.
• Prepare and update daily, monthly report and Drug Development Plan on experimental activities and results.
• Familiarity with interpretation of data generated by various developmental analytical tools including HPLC, GC, Particle size, DSC, XRD, Raman, Spectroscopic, etc.
• Assist in the general operation of the R & D formulation laboratory, including maintenance of SOP’s, training and equipment validation or maintenance.
Minimum M.S. Chemical or Life Sciences from an accredited university
Minimum 5 years related experience.
Demonstrated abilities in the areas of formulation development, lyophilization background and manufacturing are required. Experience in suspension products desired. topical dosage