Our Solutions Protect Patients! Founded in 1932, Xttrium Laboratories has been dedicated to promoting health and well-being through high-quality products. Recognized as a trusted supplier of disinfectants to hospitals and healthcare providers, Xttrium has expanded its offerings to pharmacies nationwide. With over 40 years of expertise in manufacturing FDA-registered healthcare solutions, the company is a leader in ensuring safety and quality in a health-conscious world. Xttrium is looking for an R&D Scientist.

Description:

Execute Analytical Method Verification / Validation activities of Pharmaceutical Drug Products as per current

ICH / FDA

requirements. Formulate Lab scale batches of Products and placeboes to support Analytical and formulation development. Document analytical activities and maintain data integrity as an integral part of GLP compliance. Ensure all analytical data (including electronic data and audit trial) generated in the Laboratory are meeting current standards of compliance. Keep inventory of reference standards, reagents, columns, equipment parts and order as needed. Ensure all duties and activities associated with R&D Department are carried out in compliance to FDA, OSHA, and GMP systems. Timely and effective communication to escalate Quality issues to the appropriate level of the management.

Knowledge:

Experience with the following analytical techniques: UV/Vis, IR, pH meter, wet chemistry techniques, titration, Karl Fisher titration, GC, and HPLC. Knowledge of the most current FDA/ICH guidelines and Pharmacopoeias is required. Understanding and familiarity with analytical regulatory requirement for ANDA submissions. Must possess good written and verbal communication skills.

Education:

Bachelor's or Master's Degree in scientific disciplines such as Analytical Chemistry, Pharmaceutics or Biochemistry. Minimum 1 year of experience in formulation / Analytical Chemistry, with significant knowledge of analytical chemistry techniques demonstrated through a combination of industry and academic performance. Expected compensation for this role will be $75,000 and 95,000 on a full-time basis plus applicable health and ancillary benefits offered by the company. Final compensation may differ based on a number of various factors.