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| Job #02715 |
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| About our client |
| Our client is a rapidly growing pharmaceutical company headquartered in the Midwest that is focused on the development and commercialization of therapeutic radio-pharmaceuticals for the US nuclear medicine market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. |
| Position |
Location |
| Formulation Development Director |
Midwest, USA |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Lead and manage the Formulation Development, Analytical Chemistry and Method Development Team
2) Direct activities of the scientists responsible for the development of parenteral radiopharmaceutical dosage formulations from concept through technology transfer
3) Oversee product development planning, goal setting, project cost estimating, strategic planning, and staff organization and development
4) Support clinical and regulatory affairs efforts and preparation of technology transfer documentation
5) Establish proper documentation and training in compliance with 21 CFR Part 210 and 211
6) Monitor compliance with cGMP |
| Requirements |
1) Master's in Radiochemistry, Pharmaceutics, Chemistry or a related field
2) Minimum 5 years of pharmaceutical industry experience in the development of pharmaceutical formulations
3) Experience in oncology preferred
4) Knowledge of pharmaceutical systems, especially relating to radiopharmaceuticals, raw materials and related regulatory requirements
5) Demonstrated abilities in project development, team leadership and goal achievement
6) Ability to make presentations to director-level management
7) Ability to work well in a multi-disciplinary team, including chemists,
microbiologists, pharmacologists, engineers and other scientific professionals
8) Ability to work well with regulatory bodies (FDA, NRC, etc.)
9) Excellent communication (oral and written) skills |
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