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Bioanalytical

3-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Bioanalyst

Experience Required: 3-5 years of relevant experience
Location: [Location]
Compensation: 20-25% rise on current CTC

Key Responsibilities:

  • Method Development and Validation:

    • Develop and validate analytical methods for drug molecules in biological matrices to support bioequivalence studies.

    • Analyze study samples to ensure accuracy and compliance with bioequivalence study requirements.

  • Equipment Operation:

    • Operate LC-MS/MS and other relevant analytical equipment used for bioequivalence studies.

    • Prepare batches, load and analyze samples, check results for acceptance, and identify any need for repeat or reinjection.

  • Compliance and Quality Assurance:

    • Ensure all activities comply with applicable regulatory guidelines and industry practices.

    • Maintain strict adherence to established protocols and guidelines to ensure the integrity of data and the success of bioequivalence studies.

Required Skills:

  • Proficient in using LC-MS/MS and other relevant equipment for bioanalytical testing.

  • Strong understanding of bioequivalence study requirements and bioanalytical method validation.

  • Knowledge of regulatory guidelines and compliance in bioanalytical studies.