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

    Lambda Therapeutic Research
    3-4 years
    Not Disclosed
    Ahmedabad
    10 Aug. 13, 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

    Organizational Overview:

    Lambda Therapeutic Research Ltd. is a global Contract Research Organization (CRO) specializing in conducting clinical trials.

    Job Details:

    Position: Analyst (Bioanalysis of BA/BE Studies of Biologics/Biosimilars)

    Key Deliverables:

    • Develop and validate Ligand Binding Assay (LBA) based bioanalytical pharmacokinetics (PK) methods.
    • Analyze serum samples from pre-clinical and clinical studies following draft/method SOPs.
    • Independently execute ELISA and ligand binding assays.
    • Desirable: Knowledge in PK and immunogenicity method validation.
    • Accurately and contemporaneously record data.
    • Compile, analyze, and interpret project data, method development (MD), and method validation (MV) data.
    • Write reports, SOPs, and plans.
    • Assist in root cause analysis or investigations for non-conformities and deviations.
    • Assist in the reconciliation and archival of study and validation raw data.
    • Manage inventory for critical reagents, general reagents, and consumables.
    • Create or revise SOPs for the BA-Biosimilar function.

    Allied Responsibilities:

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

    Experience:

    • 3 to 4 years of experience in bioanalysis using Ligand Binding Assays (LBA) by ELISA.

    Educational Qualification:

    • M.Sc. in Biotechnology or Biochemistry.

    Competencies:

    • Accountability: Ownership of tasks and responsibilities.
    • Communication: Effective verbal and written communication skills.
    • Work Ethic: Reliable and dedicated approach to work.
    • Initiative: Proactive problem-solving and process improvement.
    • Leadership: Ability to lead and guide team members.
    • Technical Knowledge: Expertise in bioanalytical methods and ELISA.
    • Motivation/Initiative: Drive to achieve results and improve processes.
    • Interpersonal/Leadership Skills: Ability to build relationships and lead teams.
    • Presentation/Communication Skills: Skill in presenting and communicating information.
    • Organizational Culture Fit: Alignment with company values and culture.
    • Flexibility/Planning & Organizing: Adaptability and efficient task management.

    Accomplishments & Strengths:

    • Proven achievements and strengths in method development and validation, as well as effective project management and data analysis.

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