Formulation Manager

Responsibilities- Supports and guides the formulator in new product development and costing- Designs new formulas for new products, monitors stability data of designed formulas, and prepares respective chapters of the regulatory dossier- Prepares documentation for technology transfer to production (technological instruction, batch record, risk analysis)- Performs technology transfer to production (with technology transfer report)- Supports validation activities- Supports patent review process- Provides the necessary documents for the Registration dossier when the data is available- Answer deficiency letter if necessary- Changes formulas or processes to improve the quality of current products when required- Prepare other documents and do other activities according to the manager's request- Performs equipment qualification and reviews related documentation according to the qualification plan- Support the qualification of a new source of raw material for current products- Support to resolve technical issues in production in relation to R&D- Support to resolve the issue in the formulation area (equipment issues, quality of drug product issues, development of formulation issues,…)Qualifications- Bachelor’s degree or higher in Pharmacy- Has professional knowledge and at least 10 years of experience in formulation development of pharmaceutical products in the pharmaceutical industry.- At least 5 years in a management position at formulation R&D.- Have professional knowledge in drug product development- Ability to use all equipment in the laboratory (High shear mixer, Blender, Cone mill, etc.)- Ability to analyze and solve problems- MS Office: Microsoft Excel, Word- Good command of English