a.Practical skills required in performing laboratory experiments e.g. preparation of formulations, wet chemistry testing (pH, osmolality, particulates), HPLC and other assay methods;
b. 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;
a. Design and execute small scale process studies to nominate a manufacturing process;
i. Confirm process parameters on small scale development studies (e.g. compounding, filling, sterilization and freeze drying);
ii. Evaluate compatibility and nominate contact materials;
iii. 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.
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.
Performs work in accordance with site GLP, GMP and quality requirements for pharmaceutical product development.
Perform other duties as assigned.
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
Understand properties of the drug that influence formulation design studies
March 31, 2013