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Analyst - Bioanalytical (Elisa / Lba)

0-5 years
3 LPA to 5 LPA
5 Aug. 7, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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: Analyst - Bioanalytical (ELISA / LBA)

Location: Hyderabad

Experience Required: 0 to 5 years

Employment Type: Full Time

Preferred Skills:

  • Qualification: M.Sc., B.Pharm, M.Pharm, B.Tech/M.Tech in Biotechnology
  • Handling experience with ELISA and MSD
  • Extensive experience with MD/MV of Ligand Binding Assays
  • Well-versed with bioanalytical and GLP regulations for handling bioanalytical projects

Job Description:

  • Method Development: Develop bioanalytical methods for PK, immunogenicity, and/or biomarkers in different biological matrices using LBA/ELISA techniques.
  • Method Validation and Sample Analysis: Perform method validation and sample analysis as per internal SOPs.
  • Compliance: Ensure activities conducted in the bioanalytical lab comply with established SOPs, procedures, systems, and regulatory guidance.
  • Data Management: Check data accuracy and integrity, collate data, and prepare reports.
  • Quality Assurance Interaction: Regularly interact with QA during data and report reviews, address observations, sign off reports, and handle archival.
  • Equipment Maintenance: Ensure timely calibrations and maintenance of equipment.
  • GLP Compliance: Review general documents, log-books, and calibration records to ensure GLP compliance.