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    Senior Research Associate

    Lambda Therapeutic Research
    2+ years
    Not Disclosed
    Ahmedabad
    10 Aug. 13, 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

    Organizational Overview

    Job Details:

    1. Develop and validate bioanalytical methods.
    2. Process and analyze samples for assigned projects.
    3. Operate and calibrate LC-MS/MS instruments.
    4. Adhere to system-specific and method-specific Standard Operating Procedures (SOPs) and relevant plans/protocols.
    5. Complete training on all required SOPs and documents before starting any related activities.
    6. Calibrate pH meters, pipettes, and balances in the bioanalytical laboratory.
    7. Draft and prepare SOPs and Method SOPs.
    8. Prepare and verify labels for instruments and method validation/development.
    9. Ensure effective implementation of Good Laboratory Practice (GLP) and 21 CFR Part 11 by verifying instrument labels, equipment logbooks, and ensuring timely calibration.
    10. Report the status of ongoing method development, projects, and method validation to the Group Leader/Project Manager.
    11. Communicate the performance of lab equipment and resource availability to the Group Leader/Project Manager.
    12. Continuously develop and maintain knowledge in relevant fields.
    13. Address and resolve system, project, and method validation-related findings from Reviewers/QC/QA.
    14. Report on the status of method development, projects, and validation to the Group Leader/Project Manager.
    15. Work in compliance with OECD GLP principles.
    16. Perform any other responsibilities assigned by Management or the Head of Department (HOD).

    Key Deliverables:

    • Timely and accurate development and validation of bioanalytical methods.
    • Efficient processing and analysis of samples.
    • Proper operation and calibration of laboratory instruments.
    • Compliance with GLP and regulatory requirements.
    • Effective communication and reporting on project statuses.

    Allied Responsibilities:

    • Drafting and preparation of SOPs and method documents.
    • Calibration and maintenance of lab equipment.
    • Reporting and communication with project leaders.

    Experience:

    • Proven experience in bioanalytical method development and validation.
    • Hands-on experience with LC-MS/MS instruments.
    • Familiarity with GLP and regulatory requirements.

    Educational Qualification:

    • Relevant degree in Life Sciences, Chemistry, or a related field.

    Competencies:

    • Accountability: Taking ownership of tasks and responsibilities.
    • Communication: Clear and effective verbal and written communication.
    • Work Ethic: Demonstrating reliability and dedication.
    • Initiative: Proactively addressing challenges and seeking improvements.
    • Leadership: Guiding and motivating team members.
    • Technical Knowledge: Expertise in bioanalytical methods and instrument calibration.
    • Interpersonal/Leadership Skills: Building relationships and leading teams.
    • Presentation/Communication Skills: Delivering information effectively.
    • Organizational Culture Fit: Aligning with company values and culture.
    • Flexibility/Planning & Organizing: Adapting to changes and managing tasks efficiently.

    Motivation/Initiative:

    • Demonstrated drive to achieve results and improve processes.

    Accomplishments & Strengths:

    • Previous successful projects and achievements in method development and validation.

    Organizational Culture Fit:

    • Alignment with company values and culture.

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