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Analyst - Bioanalytical (Lc-Ms/Ms)

0-5 years
Not Disclosed
10 Dec. 24, 2024
Job Description
Job Type: Full Time Education: M.Sc. / B.Pharm / M.Pharm 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: Bioanalytical Scientist
Company: Not specified in the description


Qualifications:

  • Preferred Qualifications:
    • M.Sc. / B.Pharm / M.Pharm in a relevant discipline.
    • Extensive experience in handling LC-MS/MS.
    • Strong background in method development/validation (MD/MV) of bioanalytical methods.
    • Well-versed with bioanalytical and GLP regulations for managing bioanalytical projects.

Job Description:

As a Bioanalytical Scientist, you will be responsible for conducting bioanalytical testing and ensuring the compliance of bioanalytical methods with regulatory guidelines.

Key Responsibilities:

  1. Method Development and Validation:

    • Perform method development, method validation, and study sample analysis in line with applicable methods, protocols, SOPs, and regulatory guidelines.
  2. Equipment Operation:

    • Operate key bioanalytical equipment such as HPLC, LC-MS/MS, and ELISA.
  3. Sample Analysis:

    • Conduct sample analysis and compile data within the required timelines while adhering to the applicable SOPs.
  4. Compliance with Regulatory Guidelines:

    • Ensure compliance with GLP regulations and address any audit findings from QC/QA.
    • Take appropriate actions to address audit findings, under the guidance of the Project Incharge/Group Leader.
  5. Documentation:

    • Prepare relevant documents such as Standard Operating Procedures (SOPs), method SOPs, bioanalytical protocols/plans, method validation reports, and bioanalytical study reports.
  6. Archival of Documents:

    • Ensure proper archival of method and study-related documents after the completion of the QA review.

Key Skills and Competencies:

  • In-depth knowledge of bioanalytical methods and regulatory guidelines.
  • Strong proficiency in operating LC-MS/MS, HPLC, and ELISA systems.
  • Experience in bioanalytical project management and ensuring adherence to GLP standards.
  • Ability to develop, validate, and execute bioanalytical methods in compliance with project and regulatory requirements.
  • Strong attention to detail and ability to produce high-quality documentation.

This role is critical for ensuring that bioanalytical projects meet regulatory standards and deliver results that are scientifically sound and in line with industry requirements.