Analyst - In Vitro

As an Analyst focusing on the In Vitro segment, your role will involve working with various in vitro services such as IVRT, IVPT, in vitro bioequivalence (BE) studies, BCS biowaivers, enteral feeding tube studies, or in vitro statistical analysis. While expertise in all these areas is not mandatory, you should have a solid foundation in in vitro techniques, regulatory guidelines (e.g., FDA, EMA), and data interpretation to support pharmaceutical product development. **Key Responsibilities:** - Conduct or support in vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations. - Perform in vitro bioequivalence studies and BCS biowaiver studies according to regulatory standards. - Conduct enteral feeding tube studies to evaluate drug administration compatibility. - Analyze and interpret data from in vitro studies, utilizing statistical methods when necessary. - Ensure adherence to FDA, EMA, ICH, and USP guidelines in laboratory procedures. - Prepare and review study protocols, scientific reports, and regulatory documentation. - Collaborate with cross-functional teams, including regulatory affairs and bioanalytical scientists. - Maintain laboratory equipment, follow SOPs, and ensure GLP/GMP compliance. - Basic understanding of statistical analysis for in vitro studies is advantageous. **Qualifications & Skills:** - Education: Bachelors, Masters, or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field. - Experience: Minimum of 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company. **Soft Skills:** - Strong analytical and problem-solving abilities. - Excellent written and verbal communication skills. - Quick learning capability and adaptability to new in vitro methodologies. If you are passionate about developing expertise in in vitro research and contributing to impactful pharmaceutical studies, we invite you to join us. As a leading CRO specializing in diverse in vitro research areas, you will have the opportunity to work in a collaborative and growth-oriented environment, gain exposure to multiple in vitro techniques, and expand your expertise.,