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    Research Associate - Pk / Pd Operations

    Lambda Therapeutic Research
    1-2 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

    Job Role: Analyst (BA/BE, Phase I & Phase III Studies)
    Reporting To: Head of Department/Project Head
    Department: BA-PBS
    Location: Ahmedabad
    Overall Purpose: Develop and validate LBA-based bioanalytical methods, and independently execute ELISA/ligand binding assays.

    Experience: Fresher or a minimum of 1-2 years of relevant experience.

    Educational Qualification & Expertise:

    • Degree: MSc in Biotechnology/Biochemistry
    • Skills: Experience with ELISA, MSD, cell culture techniques, and cell-based assays.
    • Knowledge: PK and immunogenicity method validation (desirable).

    Key Deliverables:

    • Develop and validate LBA-based bioanalytical methods.
    • Analyze pre-clinical and clinical samples following draft/method SOPs.
    • Serve as study personnel in GLP studies adhering to OECD principles.
    • Ensure accurate execution of method validation and study sample analysis.
    • Record and document data accurately and contemporaneously.
    • Compile, analyze, and interpret data from projects, method development (MD), and method validation (MV).
    • Write reports, SOPs, and plans.
    • Assist with root cause analysis and investigations for non-conformities or deviations.
    • Reconcile and archive study or method validation raw data.
    • Manage inventory for critical and general reagents or consumables.
    • Create or revise SOPs for the BA-Biosimilar function.

    Allied Responsibilities:

    • Perform additional tasks as assigned by the Head of the Department or Project Head.

    Experience:

    • Fresher or 1-2 years of experience in bioanalytical methods and assays.

    Educational Qualification:

    • MSc in Biotechnology/Biochemistry.

    Competencies:

    • Accountability: Ownership of tasks and responsibilities.
    • Communication: Effective verbal and written communication skills.
    • Work Ethic: Demonstrates reliability and dedication.
    • Initiative: Proactive approach to problem-solving and process improvement.
    • Leadership: Ability to guide and motivate team members.
    • Technical Knowledge: Expertise in ELISA, ligand binding assays, and cell-based assays.
    • Motivation/Initiative: Drive to achieve results and continuously improve.
    • Interpersonal/Leadership Skills: Ability to build relationships and lead effectively.
    • Presentation/Communication Skills: Skill in presenting data and information clearly.
    • Organizational Culture Fit: Alignment with company values and culture.
    • Flexibility/Planning & Organizing: Ability to adapt and manage tasks efficiently.

    Accomplishments & Strengths:

    • Demonstrated success in method development, data analysis, and documentation.
    • Effective management of bioanalytical methods and assays, contributing to high-quality results.

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