- Academic background in Chemical Engineering with strong knowledge in engineering principles and/or organic chemistry with basic understanding of cGMP/GLP requirements.
- Knowledge of analytical techniques and solid-state characterization and familiarity with statistical analysis and working knowledge of standard plant operations and safety practices
- Excellent project management skills, Strong verbal communication and presentation skills
- Willing to be hybrid as needed.
Day to Day Responsibilities: • Critically evaluate new processes for identification of process improvements and requirements necessary to prepare processes for scale up and tech transfer. • Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations. • Analyze and document the economic value of existing, proposed process solutions and new process concepts. • Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up. • Routinely monitor manufacturing processes for performance indicators and operations. • Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer. • Author, review and/or approve of process documentation needed for process validation and commercialization. • Provide support to commercial projects to support supply demand, ensure highest quality standards and guarantee patient safety. • Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis, unit operations and life cycle phase of commercial products.
Employee Value Proposition:
-Working with a cross functional team (Commercial and cross development team)