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    Study Director - Irl

    Syngene
    9-12 years
    Not Disclosed
    Bangalore
    10 Jan. 28, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Study Director - Immunogenicity Research Laboratory (IRL)
    Location: Bangalore
    Date Posted: 24th January 2025
    Experience: 9-12 years
    Designation: Senior Research Scientist - Pharmacokinetics and Immunogenicity Assays
    Department: Immunogenicity Research Laboratory

    About Syngene

    Syngene International Ltd., founded in 1993, is a global leader in innovation, providing integrated discovery, development, and manufacturing services to the pharmaceutical, biotechnology, animal health, and other industries. The company is trusted by world-class clients like Bristol-Myers Squibb, Amgen, GSK, and Herbalife. With a team of over 4,000 scientists, Syngene focuses on solving scientific problems, improving R&D productivity, accelerating time to market, and reducing innovation costs.

    Job Purpose

    The Study Director is responsible for leading and performing bioanalytical work, including ligand binding assays (LBA) related to pharmacokinetics and immunogenicity. This role involves ensuring compliance with regulatory standards, preparation of SOPs and reports, and active participation in data analysis and interpretation.

    Key Responsibilities

    1. Bioanalytical Work and Compliance:

      • Ensure all bioanalytical activities in the lab follow established SOPs, regulatory guidance, and internal procedures.
      • Review raw data and reports with the Study Director, Quality Control (QC), and Quality Assurance (QA) teams, ensuring timely closure of observations and proper archival.

    2. Study Execution and Documentation:

      • Participate in strategic planning and project execution, ensuring all tasks are completed on time.
      • Document data, analyze results, and interpret findings for presentation to stakeholders.
      • Prepare reagents, buffers, and maintain log books for assigned assays.

    3. Assay Development and Interpretation:

      • Lead the development and validation of ligand binding assays (LBA) and analyze samples.
      • Anticipate and address issues related to assay performance.
      • Prepare and present data for discussions, actively contributing to data interpretation and project decisions.

    4. Regulatory Compliance and Reporting:

      • Assist in the preparation of SOPs, protocols, and method reports.
      • Ensure compliance with regulatory standards such as OECD, GxP, 21 CFR Part 11, EMA, and FDA guidelines.

    5. Health, Safety, and Training:

      • Follow all environment, health, and safety (EHS) requirements in the workplace, ensuring safety for both individuals and lab/plant.
      • Participate in EHS training programs provided by the company.

    Educational Qualification

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

    Technical/Functional Skills

    • Immunoassays and Bioanalytical Experience: Strong background in immunoassay and bioanalytical pharmacokinetics and immunogenicity assays, including ligand binding assay (LBA) development, validation, and sample analysis.
    • Assay Knowledge: Experience with ELISA and MSD assays is highly desirable.
    • Regulatory Knowledge: Familiarity with OECD, GxP, 21 CFR Part 11, EMA, and FDA guidelines.
    • Software Proficiency: Proficient in tools like LIMS, GraphPad, Adobe, etc.
    • Manuscript Writing: Experience in writing manuscripts for publication is a plus.

    Experience

    • 9-12 years of experience in an immunoassay laboratory. Experience in a Contract Research Organization (CRO) environment is preferable.

    Behavioral Skills

    • Strong independent thinking and proactive problem-solving skills.
    • Ability to work collaboratively as part of a team.
    • Excellent written and oral communication skills in English.
    • Strong interpersonal skills and the ability to work under tight deadlines and high pressure.

    Equal Opportunity Employer

    Syngene is an equal opportunity employer and is committed to providing equal employment opportunities to all individuals regardless of race, gender, age, disability, or other protected characteristics. The company will also provide reasonable accommodations for individuals with disabilities.

    This structured job description highlights the key roles, qualifications, and responsibilities expected from the Study Director in the Immunogenicity Research Laboratory, providing clarity on the skills and experience needed for the position.

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