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Ivd Elisa - R&D (Assistant Manager)

Promea
Promea
5-6 years
Not Disclosed
10 Feb. 10, 2025
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

Job Title: IVD ELISA - R&D Assistant Manager
Experience: 5+ years
Location: Hyderabad
Employment Type: Full-Time


Job Summary:

We are seeking an experienced and highly motivated R&D Scientist to lead the development of ELISA-based products. The successful candidate will play a critical role in the design, development, optimization, and validation of ELISA kits for diagnostic and research applications. This role requires extensive hands-on experience in immunoassay development, strong troubleshooting abilities, and the capability to work collaboratively in a cross-functional environment.


Key Responsibilities:

  1. Product Development:

    • Lead the design, development, and optimization of ELISA kits and immunoassays for various diagnostic applications.
  2. Assay Optimization and Validation:

    • Optimize assay parameters (e.g., coating concentrations, detection antibody titers, incubation times) to ensure robustness, reproducibility, and sensitivity.
    • Perform rigorous validation and troubleshooting as needed to achieve desired product performance.
  3. Antibody Characterization:

    • Collaborate with antibody development teams to characterize monoclonal and polyclonal antibodies, ensuring their compatibility and performance in ELISA formats.
  4. Data Analysis and Interpretation:

    • Analyze and interpret experimental data, ensuring thorough documentation of results.
    • Provide insights and suggestions for product refinement based on data interpretation.
  5. Quality and Compliance:

    • Ensure that all ELISA products meet internal quality standards and regulatory requirements.
    • Participate in preparing regulatory submissions, documentation, and quality compliance reports.
  6. Scientific Communication:

    • Present data, progress reports, and findings to internal stakeholders.
    • Prepare technical documents, publications, and marketing materials for external communication and promotion of products.

Qualifications and Skills:

  1. Educational Background:

    • Master’s or Ph.D. in Biotechnology, Biochemistry, Immunology, or a related field.
  2. Experience:

    • Minimum of 5 years of hands-on experience in ELISA assay development with a proven track record of successful product development in diagnostics or life sciences industry.
  3. Technical Skills:

    • Strong expertise in various ELISA formats (sandwich, competitive, indirect) and other immunoassay techniques.
    • Experience in antibody conjugation, coating, and labeling techniques.
    • Proficient in assay design, development, optimization, and troubleshooting.
    • Familiarity with statistical tools for assay validation and data analysis (e.g., GraphPad Prism, Excel).
  4. Regulatory Knowledge:

    • Experience with quality management systems and regulatory guidelines such as ISO 13485, CE marking, and FDA 510(k) submission is highly advantageous.
  5. Problem-Solving:

    • Excellent analytical skills with the ability to troubleshoot complex problems and optimize experimental conditions.
  6. Communication Skills:

    • Strong verbal and written communication skills with the ability to collaborate across departments and present technical findings.

Preferred Qualifications:

  • Experience working with diagnostic or commercial ELISA kit development.
  • Knowledge of other immunoassay formats such as lateral flow assays.
  • Familiarity with protein expression, purification, and recombinant antibody technology.

This role provides an exciting opportunity to work in a dynamic environment where you will lead the development of cutting-edge diagnostic products. If you are an experienced R&D professional with expertise in ELISA assays, we invite you to apply and contribute to advancing healthcare solutions.