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    Analyst (Bioanalysis Of Ba/Be Studies Of Biologics/Biosimilar) (Research Associate)

    Lambda Therapeutic Research
    3-4 years
    Not Disclosed
    Ahmedabad
    10 Dec. 19, 2024
    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

    Job Title: Analyst (Bioanalysis of BA/BE studies of Biologics/Biosimilar) (Research Associate)
    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.
    Date: Dec 16, 2024

    Organizational Overview

    Lambda Therapeutic Research Ltd. is a global Clinical Research Organization (CRO) specializing in conducting clinical trials across various therapeutic areas. With a focus on high-quality service, Lambda has an extensive portfolio supporting biopharmaceutical and biosimilar studies worldwide.

    Job Details

    Lambda Therapeutic Research is seeking an Analyst for the Bioanalysis of BA/BE studies of Biologics/Biosimilars. The role requires expertise in the development and validation of Ligand Binding Assay (LBA)-based bioanalytical PK methods and the execution of ELISA-based assays for pre-clinical and clinical studies.

    Key Responsibilities

    • Method Development & Validation: Contribute to the development and validation of LBA-based bioanalytical PK methods for biologics/biosimilars.
    • Bioanalysis: Independently execute ELISA and ligand binding assays to analyze serum samples from pre-clinical and clinical studies according to draft/method SOPs.
    • Data Handling: Record data accurately and contemporaneously, ensuring high-quality documentation of bioanalytical results.
    • Reporting & Documentation: Prepare reports, SOPs, and plans for bioanalytical procedures.
    • Root Cause Analysis: Assist in investigations for non-conformities or deviations and contribute to root cause analysis.
    • Data Reconciliation & Archiving: Assist in the reconciliation of study data, manage archival of MD/MV/Study data, and ensure regulatory compliance.
    • Inventory Management: Assist in managing inventory for critical reagents, general reagents, and consumables.
    • SOP Creation & Revision: Contribute to the creation and revision of new system SOPs for the BA-Biosimilar function.

    Key Deliverables

    • Development and validation of LBA-based bioanalytical methods.
    • Accurate execution and documentation of ELISA and ligand binding assays.
    • Timely preparation and submission of bioanalytical reports and SOPs.
    • Effective data analysis, interpretation, and reconciliation for clinical and pre-clinical studies.
    • Efficient inventory management of reagents and consumables.
    • Root cause analysis for non-conformities and deviations to ensure smooth operations.

    Experience

    • 3 to 4 years of experience in bioanalysis, specifically in Ligand Binding Assays (LBA) by ELISA.

    Educational Qualification

    • M.Sc. in Biotechnology/Biochemistry or related fields.

    Competencies

    • Accountability: Demonstrates responsibility in performing tasks with accuracy and integrity.
    • Communication: Strong communication skills for report writing and team collaboration.
    • Work Ethic: Diligent, efficient, and committed to high standards.
    • Initiative: Proactively addresses issues and contributes to continuous improvement.
    • Leadership: Ability to guide and support junior team members when required.
    • Technical Knowledge: Deep understanding of bioanalytical techniques and bioassay methods.
    • Motivation/Initiative: Strong drive to achieve goals and deliver results.
    • Interpersonal Skills: Able to work effectively in a collaborative team environment.
    • Presentation/Communication Skills: Capable of presenting findings clearly to internal and external stakeholders.
    • Organizational Culture Fit: Aligns with the organization's mission, values, and culture.

    Why Lambda?

    Lambda Therapeutic Research provides an excellent work environment for those seeking to advance their career in bioanalysis and clinical research. As part of a global CRO, the candidate will have the opportunity to work on cutting-edge biologics and biosimilar studies, enhancing skills and contributing to the advancement of medical research.

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