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

    Lambda Therapeutic Research
    3-4 years
    Preferred by Comapny
    Ahmedabad
    12 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: M.Sc. in Biotechnology/Biochemistry 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/Biosimilars)

    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO), specializing in conducting clinical trials across diverse therapeutic areas. The company is known for its high standards in clinical research and bioanalytical testing, supporting the global pharmaceutical, biotech, and medical industries.

    Position Overview

    The Analyst will be responsible for performing bioanalytical testing and validation of Ligand Binding Assays (LBA) for pharmacokinetic (PK) studies, as well as analyzing serum samples for pre-clinical and clinical studies. This role requires independent execution of ELISA and ligand binding assays and ensuring compliance with Standard Operating Procedures (SOPs) while providing analytical support for various studies related to biologics and biosimilars.

    Key Responsibilities

    Bioanalysis & Method Validation

    • Act as an Analyst for the development and validation of LBA-based bioanalytical PK methods.
    • Independently execute ELISA and ligand binding assays for pre-clinical and clinical serum samples as per the relevant draft/method SOPs.
    • Ensure accurate recording of all data, ensuring contemporaneous documentation of bioanalytical results.
    • Perform analysis and interpretation of Project/MD/MV data, compiling findings in reports and documents.
    • Assist in root cause analysis or investigations for non-conformities or deviations, ensuring thorough investigation and resolution.

    Documentation & SOP Management

    • Write and maintain reports, SOPs, and study plans, ensuring compliance with established guidelines.
    • Assist in the archival of MD/MV/Study data for regulatory submission and internal record-keeping.
    • Participate in the reconciliation of study or MV raw data, ensuring accuracy and integrity in all records.

    Inventory & System Management

    • Assist in the management of inventory for critical reagents, consumables, and other general reagents used in the lab.
    • Create new SOPs or revise existing ones for the BA-Biosimilar function to improve system efficiencies and standards.

    Collaborative Responsibilities

    • Collaborate with team members and the department head for continuous process improvement and ensure quality standards are met.
    • Support any additional responsibilities as assigned by the Head of the Department or Project Head.

    Experience & Qualifications

    Experience

    • 3 to 4 years of experience in bioanalysis of Ligand Binding Assays (LBA), particularly through ELISAtechniques.

    Educational Qualifications

    • A Master’s degree (M.Sc.) in Biotechnology or Biochemistry is required.

    Key Competencies

    • Accountability: Ability to take ownership of tasks and ensure all responsibilities are completed on time and to a high standard.
    • Communication: Strong communication skills, both verbal and written, for clear reporting and collaboration.
    • Work Ethic: High attention to detail and a strong commitment to accuracy in bioanalytical testing.
    • Initiative: Proactive in solving problems and suggesting process improvements.
    • Leadership: Capable of guiding junior team members and collaborating effectively with colleagues.
    • Technical Knowledge: In-depth knowledge of bioanalytical techniques such as ELISA and ligand binding assays, along with PK and Immunogenicity method validation.
    • Flexibility/Planning & Organizing: Effective in managing multiple tasks and adapting to changing priorities.

    Why Join Lambda Therapeutic Research?

    Lambda Therapeutic Research Ltd. offers a dynamic and challenging work environment with opportunities for professional growth and development in the clinical research and bioanalysis sectors. The company supports cutting-edge studies in biologics and biosimilars, providing a platform for employees to advance their skills and contribute to global healthcare innovation.

    Lambda Therapeutic Research Ltd.

    Join Lambda's mission to advance clinical research and contribute to the development of life-saving biologics and biosimilars worldwide.

    This position offers a key role in ensuring the success of clinical trials and providing high-quality bioanalytical testing for innovative therapeutics.

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