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Bioanalytical

Indivirtus
Indivirtus
3-5 years
Not Disclosed
2 Feb. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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: 3-5 years of relevant experience

Salary: 20-25% rise on current CTC

Job Responsibilities:

  1. Analytical Method Development & Validation:

    • Develop and validate robust analytical methods for the quantification of drug molecules in biological matrices such as plasma, serum, and urine.
    • Ensure method validation complies with regulatory guidelines, including precision, accuracy, sensitivity, and selectivity.
  2. Bioequivalence Study Sample Analysis:

    • Perform bioanalytical testing of study samples to assess bioequivalence between test and reference drug formulations.
    • Conduct quantitative analysis of drug concentrations in biological matrices using validated methods.
  3. LC-MS/MS Operation & Maintenance:

    • Operate, calibrate, and maintain LC-MS/MS (Liquid Chromatography-Mass Spectrometry) and other relevant analytical instruments.
    • Troubleshoot instrument-related issues and optimize method parameters for accurate results.
  4. Sample Handling & Data Review:

    • Prepare study batches, load and analyze biological samples, and document analytical procedures meticulously.
    • Review data for accuracy, identify any deviations, and determine the need for reinjection or repeat analysis.
  5. Regulatory Compliance & Documentation:

    • Ensure adherence to regulatory guidelines such as USFDA, EMA, ICH, and GLP (Good Laboratory Practice).
    • Maintain accurate documentation, including method validation reports, standard operating procedures (SOPs), and regulatory submissions.
    • Stay updated with evolving bioanalytical regulatory requirements and industry best practices.