Novitium Pharma LLC
Website:
novitiumpharma.com
Job details:
Company Description Novitium Pharma LLC is a U.S.-based pharmaceutical company specializing in the development, manufacturing, and distribution of niche generic products. Founded in 2016, the company has built a growing commercial portfolio and a robust pipeline with over 20 ANDAs filed with the FDA across diverse dosage forms and therapeutic categories. Novitium focuses on delivering affordable, high-quality medications that support pharmacists in serving patients and communities. The organization continues to invest in innovation, compliance, and operational excellence to expand access to essential therapies.
Role Description This is a full-time, on-site role based in Chennai for an IVRT/IVPT expert with advanced experience in LC-MS/MS, GC-MS, and ICP-MS. The role involves designing and conducting in vitro release testing (IVRT) and in vitro permeation testing (IVPT) studies for topical and transdermal formulations in accordance with regulatory and scientific guidelines. The specialist will develop, validate, and optimize analytical methods using LC-MS/MS, GC-MS, and ICP-MS, and ensure accurate generation, interpretation, and documentation of data. Daily responsibilities include preparing test protocols and reports, coordinating with formulation and analytical teams, troubleshooting analytical issues and instruments, and maintaining rigorous quality, safety, and compliance standards. The role also requires active participation in regulatory submissions, audits, and continuous improvement initiatives within the laboratory.
Qualifications
- Strong expertise in IVRT and IVPT study design, execution, data analysis, and documentation for topical/transdermal products.
- Hands-on proficiency with LC-MS/MS, including method development, validation, sample preparation, and instrument troubleshooting.
- Working experience with GC-MS, including chromatographic method optimization, identification/quantification of analytes, and maintenance of equipment.
- Practical knowledge of ICP-MS for elemental analysis, method validation, and adherence to relevant pharmacopeial and regulatory requirements.
- Solid understanding of pharmaceutical analytical chemistry, bioanalytical principles, and topical formulation science.
- Familiarity with FDA, EMA, and ICH guidelines related to IVRT/IVPT, method validation, data integrity, and cGMP/cGLP compliance.
- Competence in statistical analysis of IVRT/IVPT data and use of relevant software for data processing and reporting.
- Experience preparing technical reports, SOPs, validation protocols, and contributing to regulatory submissions (e.g., ANDAs).
- Strong attention to detail, organizational skills, and ability to manage multiple studies and timelines in a laboratory environment.
- Effective written and verbal communication skills and ability to collaborate with cross-functional teams in R&D, QA, and manufacturing.
- Master’s or PhD in Pharmaceutical Sciences, Analytical Chemistry, or related field; significant
Click on Apply to know more.