Analyst - In Vitro
VitelyBio
Date: 3 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time

Job Summary
We are looking for a versatile Analyst focusing on our In Vitro segment with experience in one or more of our 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 required, candidates should have a strong foundation in in vitro techniques, regulatory guidelines (eg: FDA, EMA), and data interpretation to support pharmaceutical product development.
Key Responsibilities
We are looking for a versatile Analyst focusing on our In Vitro segment with experience in one or more of our 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 required, candidates should have a strong foundation in in vitro techniques, regulatory guidelines (eg: FDA, EMA), and data interpretation to support pharmaceutical product development.
Key Responsibilities
- Conduct or support one or more of the following:
- In vitro release testing (IVRT) and in vitro permeation testing (IVPT) for pharmaceutical formulations.
- In vitro bioequivalence studies and BCS biowaiver studies as per regulatory standards.
- Enteral feeding tube studies to assess drug administration compatibility.
- Analysis and interpretation of data from in vitro studies, applying statistical methods where required.
- Ensure compliance with 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 a plus.
- Education: Bachelor’s, Master’s or Ph.D. in Pharmaceutical Sciences, Biopharmaceutics, Analytical Chemistry, or a related field.
- Experience: At least 2 years of experience in any in vitro research area, preferably within a CRO or pharmaceutical company.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Ability to learn quickly and adapt to new in vitro methodologies.
- Work with a leading CRO specializing in diverse in vitro research areas.
- Gain exposure to multiple in vitro techniques and expand your expertise.
- Collaborative and growth-oriented work environment.
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