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Ivd Elisa - R&D (Assistant Manager)

5+ years
Not Disclosed
10 Dec. 5, 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

Job Title: R&D Scientist (ELISA Development)

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:

  • Product Development: Lead the design, development, and optimization of ELISA kits and immunoassays for various diagnostic applications.
  • Assay Optimization and Validation: Optimize assay parameters (e.g., coating concentrations, detection antibody titers, incubation times) for robustness, reproducibility, and sensitivity. Perform validation and troubleshooting as needed.
  • Antibody Characterization: Collaborate with antibody development teams to characterize monoclonal and polyclonal antibodies and ensure compatibility in ELISA formats.
  • Data Analysis and Interpretation: Analyze experimental data, ensure thorough documentation, and provide insights for product refinement.
  • Quality and Compliance: Ensure ELISA products meet quality standards and regulatory requirements, contributing to regulatory submissions and documentation.
  • Scientific Communication: Present data and findings to internal stakeholders and prepare technical documents, publications, and marketing materials for external communication.

Qualifications and Skills:

  • Educational Background: Master’s or Ph.D. in Biotechnology, Biochemistry, Immunology, or a related field.
  • Experience: Minimum of 5 years of hands-on experience in ELISA assay development, with a proven track record in diagnostics or life sciences.
  • Technical Skills: Expertise in ELISA (sandwich, competitive, indirect) and other immunoassay techniques, antibody conjugation, and assay design. Proficiency with statistical tools (e.g., GraphPad Prism, Excel).
  • Regulatory Knowledge: Experience with ISO 13485, CE marking, and FDA 510(k) submission is a plus.
  • Problem-Solving: Strong analytical and troubleshooting skills.
  • Communication Skills: Excellent verbal and written communication skills for cross-departmental collaboration.

Preferred Qualifications:

  • Experience 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.