R&D Analytical Senior Scientist I
Location: Columbus, OH
Currently working with global manufacturer that supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
This global leading manufacturing company is looking to keep on expanding and is currently seeking to add an Analytical Senior Scientist to their R&D team.
Duties and Responsibilities
- Leading the development, optimization, and validation activities of analytical methods for multiple projects simultaneously.
- Lead technical transfer services of analytical methodologies from the clinical to commercial application.
- Plan and execute requisite lab work to answer FDA deficiency questions and Complete Response Letter for submitted ANDA.
- Master's Degree or Ph.D. with minimum 5-10 years of pharmaceutical industry experience in method development and validation required.
- Demonstrated expertise with HPLC, GC, IC, LC-MS, dissolution instrumentations.
- Experience managing multiple projects simultaneously.
- Strong technical writing skills required.