8 Immunoassay Jobs

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requires collaboration with cross-functional teams to ensure timely and accurate preparation of regulatory documents , risk files, and performance data packages for international regulatory approvals. Familiarity with immunoassays, including ELISA and fluorescence-based methods, particularly for infectious disease diagnostics, is preferred. Key Responsibilities: 1. Performance Evaluation Documentation: Author and maintain IVDR-mandated performance evaluation documents, including: Scientific Validity Reports (SVRs) Analytical Performance Reports (APRs) Clinical Performance Reports (CPRs) Performance Evaluation Reports (PERs) Ensure alignment with EU IVDR Annex XIII, MDCG guidelines, and ISO standards. Compile and interpret data from internal validations, clinical studies, and external literature. Coordinate with laboratory/R&D teams to ensure appropriate data generation for APRs and CPRs. 2. Scientific Validity & Literature Review: Conduct systematic literature searches using PubMed, Embase, Scopus, and other databases. Define and document search strategies, selection criteria, and appraisal methodology. Evaluate and synthesize scientific evidence supporting biomarkercondition associations. Develop literature matrices, evidence tables, and justification summaries for SVRs. 3. Regulatory Documentation & Global Registration Support: Prepare and maintain CE Technical Files/Design Dossiers and ensure alignment with GSPRs. Support global product registration activities by preparing and submitting regulatory documentation as per country-specific requirements. Ensure timely preparation and submission of documents for new market approvals and renewals. Assist in regulatory gap assessments and remediation planning for international markets. Contribute to Risk Management Files (ISO 14971) and Post-Market Performance Follow-up (PMPF) documentation. 4. Cross-Functional Coordination & Audit Support: Collaborate with RA, QA, R&D, PMS, and manufacturing teams for data collection and alignment. Participate in internal audits and assist with responses to Notified Body and regulatory authority observations. Support vigilance reporting and post-market analysis through literature and performance data review. Required Skills & Experience: 5-7 years of experience in regulatory affairs and clinical/performance documentation for IVDs or medical devices. In-depth knowledge of EU IVDR, ISO 13485, ISO 20916, CLSI guidelines, and applicable international regulatory standards. Proven experience in preparing performance evaluation documents and conducting systematic literature reviews. Strong understanding of immunoassay technologies and infectious disease diagnostics. Excellent documentation, data analysis, and regulatory writing skills.

Marketing mapping Understand client needs & develop revenue pipeline in alignment with the BD strategy Identifying new biz opportunities & capitalize Negotiate & close contracts/agreements as per policy Farming existing clients & ensuring growth Required Candidate profile Manage & develop customer relationship & customer satisfaction Client retention Responsible for cross dept. collaboration across Co for smooth operations Responsible for sales for the assigned area

Summary Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites. About The Role Your responsibilities include, but are not limited to: Independently provide operational support to Biomarker Study Experts and clinical studies focusing on biomarker samples and including reviews of clinical study protocol, preparing site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample operation logistics and coordination including study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure Support data transfer and data flows in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant reports and IT systems Independently identify and resolve sample management and sample discrepancy issues Identify, and escalate issues, ESP, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed. Contribute to the best practices, process. Continuous improvement initiatives and innovations in sample management functions Collaborate with other TM, BMD and GCO functions BS in life science with 4+ years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. Advance degree with 2 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers Operational knowledge of clinical trials: clinical study set up, clinical sample management, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors Laboratory background and knowledge immunoassay and/or bioanalysis Knowledge of the drug development process, clinical biomarkers and working with translation clinical research. Strong project and time management skills, problem solving, communication and leadership skills. Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while were proud of this, we know there is so much more we could do to help improve and extend peoples lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the worlds toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment To Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network,

Role - Application Specialist - Immunoassay Location - Jaipur Industry - Diagnostic Responsibilities 1. Customer training on the use of our immunoassay automation solutions 2. Ensure quality customer training as per guidelines and documentation. 3. Provide high levels of customer support in the territory and maintain customer satisfaction levels. 4. Troubleshooting at customer site for resolution of issues with results on our systems and reagents. 5. Promotion of special parameters on platforms. 6. Achieve sales objectives and assist the team to promote our solutions. 7. Participation in CMEs, scientific conferences and other settings to build upon the brand value of our solutions Interested can share their CV at kshama.k @ head2hire.com or +917290007914 Thanks & Regards Kshama Kulshrestha

1) Sample Handling and Processing: 2) Performing Diagnostic Tests-Conduct routine diagnostic procedures in areas like Bio-chemistry, hematology, microbiology, and immunology 3) Operate and maintain various laboratory equipment, including microscopes, centrifuges, and automated analyzers 4) Interpret test results and report findings accurately 5) Quality Control and Safety 6) Technical Support:Provide technical support to other laboratory staff and healthcare professionals.

1) Sample Handling and Processing: 2) Performing Diagnostic Tests-Conduct routine diagnostic procedures in areas like Bio-chemistry, hematology, microbiology, and immunology 3) Operate and maintain various laboratory equipment, including microscopes, centrifuges, and automated analyzers 4) Interpret test results and report findings accurately 5) Quality Control and Safety 6) Technical Support:Provide technical support to other laboratory staff and healthcare professionals.

1) Sample Handling and Processing: 2) Performing Diagnostic Tests-Conduct routine diagnostic procedures in areas like Bio-chemistry, hematology, microbiology, and immunology 3) Operate and maintain various laboratory equipment, including microscopes, centrifuges, and automated analyzers 4) Interpret test results and report findings accurately 5) Quality Control and Safety 6) Technical Support:Provide technical support to other laboratory staff and healthcare professionals.

Location- Location: Delhi | Ahmedabad | Surat | Mumbai | Nagpur | Bangalore | Kochi | Coimbatore | Bhubaneswar | Guwahati Role & responsibilities About the Role We are looking for a skilled and customer-focused Field Service Engineer to manage installation, breakdown service, and preventive maintenance of IVD diagnostic instruments across assigned territories. This is a hands-on, field-based role requiring strong technical acumen, customer engagement skills, and discipline in documentation and follow-up. Key Responsibilities 1. Installation & Breakdown Handling Install diagnostic instruments at customer sites, ensuring complete validation and handover Attend breakdown calls promptly and resolve issues to ensure minimal downtime Coordinate with application and product teams for any advanced troubleshooting support 2. Preventive Maintenance (PM) Perform scheduled preventive maintenance as per SOPs and PM calendar Ensure completion of PM documentation and customer sign-off on service reports Flag recurring issues or deterioration in instrument performance to senior engineers or managers 3. Customer Engagement & Support Maintain a professional and proactive relationship with customers Train users on instrument handling and maintenance best practices Promote new tests and features in installed systems where relevant (cross-selling mindset) 4. Documentation & Compliance Complete all service call documentation, including call reports, PM checklists, and part usage Maintain discipline in Helpdesk and CRM updates, field reporting, and escalation protocols Ensure compliance with safety and quality standards at customer sites Preferred candidate profile Qualifications & Experience – Diploma or Degree in Biomedical, Electronics, Instrumentation, or related engineering field – 2–5 years of experience in service of medical diagnostic instruments – Experience with , CLIA automation is preferred Skills & Competencies – Strong technical troubleshooting and repair skills – Good communication and customer handling skills – Organized, self-motivated, and process-driven – Willing to travel extensively in the assigned territory