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Senior Research Associate - CMC (Chemistry, Manufacturing, and Controls)
Perform research and/or development in collaboration with others on new formulations and reformulates existing products in accordance with agreed upon departmental projects taking into account scientific and timing objectives.
Key Job Responsibilities:
- Apply sound scientific practices to assist commercial formulation development efforts for a high visibility product
- Involved in the development of preclinical and clinical formulations
- Conduct stability studies and evaluates characteristics of raw materials and experimental batches
- Perform experiments leading to the development of rational, scientifically sound formulations and manufacturing processes
- Run analytical techniques, including HPLC, DSC, dissolution, microscopy, etc.
- Assist with preparation of placebo and active formulations and provide support on other regulatory submissions
- Implement production and lab-scale manufacturing procedures to optimize processes and regulatory requirements
- Responsibility includes scale-up and troubleshooting for equipment and systems
- Establish operating equipment specifications and improve manufacturing techniques
- Assist with resolving technical issues, as well as maintenance of production and lab equipment as appropriate
Requirements:
- Bachelors degree in Pharmaceutical Sciences, Chemistry or extensive experience in related engineering field
- 5+ years related experience
- Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought
- Good knowledge of scientific principles and concepts
- Thorough and working understanding of chemistry, formulation, and process chemistry including related instrumentation, troubleshooting, method development, implementation, etc
- Keen attention to detail
- Strong work ethic and thrives in a team environment
- Ability to communicate clearly and effectively
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