Senior Scientist - Extractractable and Leachables and Nitrosamine Speciality

Company Description

Novitium Pharma LLC is a progressive U.S.-based pharmaceutical company established in 2016, dedicated to the development, manufacturing, and distribution of niche generic products. With over 20 ANDAs filed with the FDA, the company has built a diverse and growing product portfolio spanning various dosage forms and therapeutic categories. Novitium is committed to delivering affordable, high-quality medications to fulfill the needs of patients, pharmacists, and communities. The company continues to invest in innovation and excellence in its offerings.

Role Description

We are seeking a Senior Scientist specializing in Extractables and Leachables (E&L) and Nitrosamine to join our team in Chennai, India. This is a full-time, on-site position. The Senior Scientist will lead and oversee analytical testing and assessments related to E&L and Nitrosamine impurities in pharmaceutical products. The role involves developing and validating analytical methods, conducting risk assessments, documenting study results, and ensuring compliance with regulatory standards. Additionally, the individual will collaborate closely with cross-functional teams, support regulatory submissions, and contribute to continuous improvement initiatives.

Qualifications

• Proficiency in techniques such as Chromatography (HPLC, GC) and Mass Spectrometry (LC-MS, GC-MS)
• Experience in Extractables & Leachables (E&L) analysis, assessment, planning and execution
• Nitrosamines and NDSRI impurity analysis
• Expertise in analytical method development, validation, and regulatory submissions
• Strong background in regulatory compliance, including USP, FDA, and ICH guidelines
• Exceptional problem-solving skills and ability to conduct risk assessments
• Strong written and verbal communication skills for preparing technical reports and documentation
• Ph.D. or Master's degree in Analytical Chemistry, Chemistry, or related scientific discipline, with relevant experience in the pharmaceutical industry
• Ability to work collaboratively in cross-functional teams and prioritize tasks effectively