Pharmaceutical Bioequivalence Scientist NOVUMGEN
NOVUMGEN
Office Location
Full Time
Experience: 4 - 4 years required
Pay:
Salary Information not included
Type: Full Time
Location: Gujarat
Skills: Pharmacokinetics, pharmacology, Clinical Research, Regulatory Guidelines, Bioanalytical, Data Analysis, Statistical Analysis, Compliance, Good Clinical Practice GCP, Good Laboratory Practice GLP, Scientific Expertise, Problemsolving, Pharmacokinetic Analysis
About NOVUMGEN
Job Description
Job Summary: We are seeking a highly motivated and detail-oriented Bioequivalence Scientist to join our team. The role involves conducting bioequivalence studies to assess the equivalence of generic drugs to their reference counterparts. The ideal candidate will have a strong background in pharmacokinetics, pharmacology, and clinical research, with a focus on ensuring compliance with regulatory guidelines and maintaining high scientific standards. Key Responsibilities: 1. Study Design and Planning - Designing bioequivalence studies based on regulatory requirements and scientific principles. - Developing study protocols and ensuring they meet all necessary criteria. 2. Execution and Oversight: - Managing or overseeing the execution of bioanalytical and clinical components of BE studies. - Collaborating with cross-functional teams including clinical operations, data management, and biostatistics. 3. Data Analysis and Interpretation: - Analyzing pharmacokinetic data and performing statistical analysis to determine bioequivalence. - Interpreting results and preparing study reports for regulatory submissions. 4. Quality Assurance and Compliance: - Ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulatory guidelines (FDA, EMA, TGA, Health Canada, etc.). - Participating in audits and inspections related to bioequivalence studies. 5. Scientific Support: - Providing scientific expertise and guidance to internal teams and external collaborators. - Keeping abreast of industry trends, scientific advancements, and regulatory updates related to BE. Qualifications - Master's or PhD in Pharmacology, Pharmaceutical Sciences, or related field. - Previous experience (typically 4-6 years) in conducting bioequivalence studies (bio-analytical is preferred) - Strong knowledge of pharmacokinetics, biostatistics, and clinical trial methodologies. - Ability to work independently and collaboratively in a team-oriented environment. - Detail-oriented with strong organizational and problem-solving skills. - Knowledge of software tools used for pharmacokinetic analysis.,