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    Analyst

    Syngene
    0-3 years
    Not Disclosed
    Bangalore
    10 Oct. 25, 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

    Date: 22 Oct 2024
    Location: Bangalore
    Pay Grade: 9-I
    Experience Required: 0 - 3 Years

    About Syngene

    Syngene International Ltd. (BSE: 539268, NSE: SYNGENE) is a leading integrated research, development, and manufacturing services company. We serve a diverse range of sectors including pharmaceuticals, biotechnology, nutrition, and specialty chemicals. With over 4,500 scientists, we excel in delivering robust science, data management, and quality manufacturing to enhance innovation and reduce time-to-market. Our state-of-the-art facilities support collaborations with major biotech companies and multinationals like GSK and Merck KGaA.

    Job Purpose

    The Research Associate will perform bioanalytical tasks, focusing on ligand binding assays related to Pharmacokinetics and Immunogenicity.

    Key Responsibilities

    • Conduct bioanalytical lab activities in compliance with established SOPs, procedures, and regulatory guidance.
    • Collaborate with Study Directors, QC, and QA during data review and observation closure.
    • Complete assigned tasks in a timely manner.
    • Prepare reagents and maintain logs for assigned assays.
    • Interpret assay results and identify potential issues.
    • Participate in data discussions and presentations.
    • Adhere to environment, health, and safety (EHS) requirements to ensure workplace safety.
    • Attend EHS training provided by the company.

    Educational Qualification

    • Master’s degree in Biological Sciences (preferably with a background in Biochemistry) or a related field.

    Technical/Functional Skills

    • Strong foundation in immunoassays and bioanalytical Pharmacokinetics and Immunogenicity Assays, aligned with regulatory guidance and industry practices.
    • Hands-on experience in Ligand Binding Assay (LBA) development, validation, and sample analysis; knowledge of ELISA and MSD assays is desirable.
    • Familiarity with regulatory requirements (OECD, GXP, 21 CFR Part 11, EMA, and FDA guidelines).

    Experience

    • 0-3 years of experience in Pharmacokinetics and Immunogenicity Assays.

    Behavioral Skills

    • Independent and proactive.
    • Excellent communication skills (written and oral) in English.
    • Strong interpersonal abilities.
    • Flexible and capable of working under time pressure.

    Equal Opportunity Employer

    Syngene is committed to providing equal employment opportunities to all individuals regardless of age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity, or any other characteristic protected by law. We also offer reasonable accommodations for qualified individuals with disabilities.

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