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Analyst - Bioanalytical (Elisa/Lba)

0-5 years
Not Disclosed
10 Feb. 10, 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

Preferred Skills:

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

 

Job Description:

  • Develop bioanalytical methods for PK, Immunogenicity and/or biomarkers in different biological matrices using LBA/ELISA techniques.
  • Perform Method validation and sample analysis as per internal SOPs.
  • Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance.
  • Checking of data accuracy and integrity, data collation and report preparation.
  • Regular interaction with QA (Quality Assurance) during data and reports review, closure of observations, reports sign off and archival.
  • Ensure timely calibrations and maintenance of equipment.
  • Reviewing of general documents, log-books, calibration records to ensure GLP compliance.