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Analyst (Elisa / Lba)

0-3 years
3-6 Lacs P.A.
12 May 16, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Job Role: Analyst (BA/BE & Phase I studies)

Designation: Research Associate

Reporting To: Head of Department / Project Head

Department: Bioanalytical-Protein Biosimilar

Location: Ahmedabad

Overall Purpose: Develop and validate LBA based bioanalytical methods. Independently execute ELISA/ligand binding assays.

Experience: Fresher or Minimum 1-2 years of experience

Educational Qualification: MSc in Biotechnology/Biochemistry

Expertise:

  • Sound knowledge in ELISA, MSD, Cell Culture techniques.
  • Independent execution of ELISA/ligand binding assays.
  • Cell-based assays.
  • Data analysis and recording.
  • Manage documentation Plans and Reports.
  • Knowledge of cell-based assay is desirable.
  • Knowledge of PK and Immunogenicity method validation is desirable.

Key Deliverables:

  • Act as an Analyst for development, validation, and study sample analysis of LBA based bioanalytical methods.
  • Analyze samples of pre-clinical and clinical studies as per respective draft method SOPs/method SOPs.
  • Act as study personnel in GLP studies and follow OECD principles.
  • Ensure flawless execution of method validation and study sample analysis experiments.
  • Record data accurately and contemporaneously.
  • Compilation, analysis, and interpretation of Projects/MD/MV data.
  • Write reports, SOPs, and plans.
  • Assist in root cause analysis or investigations for non-conformities/deviations.
  • Assist in reconciliation of study or MV raw data.
  • Assist in archival of MD/MV/Study data.
  • Assist in management of inventory for critical reagents or general reagents or consumables.
  • Create new system SOPs or revise existing SOPs of BA-Biosimilar function.

Role: Research Associate / Engineer

Industry Type: Clinical Research / Contract Research

Department: Research & Development

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical & Biotechnology

Education:

  • UG: B.Tech/B.E. in Bio-Chemistry/Bio-Technology
  • PG: MS/M.Sc(Science) in Biotechnology, Bio-Chemistry, M.Tech in Bio-Chemistry/Bio-Technology