Senior Formulation Scientist
Sigmar Recruitment
Galway
Our client are a multinational pharmaceutical company based about 30 minutes out side of Galway city. They require a Senior Formulation Scientist to join their team. Call Rachael on 091 455306 or email rbrennan@sigmar.ie to find out more. Responsibilities: Supports at least 2-3 Injectable projects and take ownership of ensuring assigned project activities are meeting predefined milestones. Design and execute experimental studies using QbD principles to nominate formulations and select primary packaging. Practical skills required in performing laboratory experiments e.g. preparation of formulations, wet chemistry testing (pH, osmolality, particulates), HPLC and other assaymethods. Basic understanding of statistics to support DOEs, data analysis and interpretation. Knowledge of manufacturing processes used for sterile liquid/lyophile products which enables design of scale up studies for injectable products. Design and execute small scale process studies to nominate a manufacturing process; Confirm process parameters on small scale development studies (e.g. compounding, filling,sterilization and freeze drying. Evaluate compatibility and nominate contact materials; Perform filter studies and autoclaving trials. Lead and execute activities required for scale up and tech transfer into a production plant. Write up concise clear reports with recommendations and support preparation of GMP documentation for technical transfer batch manufacture. Independently review and interpret data making technical decisions/recommendations for management approval that directly influence development plans for products. Provide technical leadership on assigned products across the Product Development project team and works collaboratively with other departments. Qualifications: Minimum of a Bachelor’s degree in a science related discipline (Preferably Chemistry or Biotechnology) with 6+ years’ experience within a formulation role. Practical skills required in performing laboratory experiments e.g. preparation formulations, wet chemistry testing (pH, osmolality, particulates), HPLC, UV, Karl Fischer and other assay methods. Characterization methods for Solution and Lyophile products (e.g. DSC/TGA and water analysis. Ability to perform and supervise scale up activities for technical transfer to GMP plant. Requires a high level of scientific knowledge and expertise in product and formulation development. Knowledge of Quality systems, GMP and GLP requirements for pharmaceutical development. Proficiency in speaking, comprehending, reading and writing English is required. To apply please send your CV to rbrennan@sigmar.ie or call Rachael on 091 455306. All applications are dealt with in strict confidence. Sigmar will never send your CV to a third party without your consent. This job originally appeared on RecruitIreland.com.
2530 days ago