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Analyst - Bioanalytical (Elisa / Lba)

0-5 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: M.Sc. / B.Pharm / M.Pharm / B.Tech/M.Tech-Biotechnology 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

Here’s the refined version of your job posting:


Preferred Skills

  • Qualifications:
    • M.Sc., B.Pharm, M.Pharm, B.Tech, or M.Tech in Biotechnology.
  • Technical Expertise:
    • Hands-on experience with ELISA and MSD (Meso Scale Discovery) platforms.
  • Specialized Experience:
    • Extensive expertise in Method Development (MD) and Method Validation (MV) for Ligand Binding Assays (LBA).
  • Regulatory Knowledge:
    • Proficient in bioanalytical and GLP regulations for managing bioanalytical projects.

Job Description

Key Responsibilities

  1. Bioanalytical Method Development

    • Develop bioanalytical methods for Pharmacokinetics (PK), Immunogenicity, and/or Biomarkers across various biological matrices using LBA/ELISA techniques.
  2. Method Validation and Sample Analysis

    • Perform method validation and sample analysis in strict compliance with internal SOPs and regulatory guidelines.
  3. Regulatory and Quality Compliance

    • Ensure all activities within the bioanalytical lab adhere to established SOPs, systems, and regulatory guidance.
    • Collaborate with QA for data and report reviews, addressing observations, ensuring report sign-offs, and managing document archival.
  4. Data Management

    • Check data accuracy and integrity, collate data, and prepare comprehensive reports.
  5. Equipment Calibration and Maintenance

    • Ensure timely calibration, maintenance, and troubleshooting of laboratory equipment.
  6. GLP Compliance

    • Review general documents, logbooks, and calibration records to ensure compliance with Good Laboratory Practices (GLP).

This role requires a detail-oriented professional with robust technical and regulatory expertise, capable of maintaining data integrity and fostering a culture of compliance. If you have a passion for bioanalytical research and method development, this position offers an excellent platform for growth and innovation.

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