Immunogenicity Specialist

Description

Job Summary: We are seeking an innovative professional to develop and validate immunogenicity assays, interpret clinical data, and provide regulatory technical support. Key Highlights: 1. Development and validation of immunogenicity assays. 2. Interpretation of clinical data and correlation with safety/efficacy. 3. Regulatory technical support and participation in laboratory setup. To join our team, we seek professionals who wish to contribute to our mission of **improving the lives of increasingly more people.** If you possess an innovative mindset, think outside the box, and enjoy working in a modern and dynamic environment, this opportunity is for you. Join us on this journey. **\#JoinSynvia** **Responsibilities and Duties** **We count on you to:** * Develop, optimize, and validate immunogenicity assays for anti-drug antibody (ADA) detection using a tiered approach (screening, confirmation, and titration). * Develop and validate neutralizing antibody (nAb) assays, including cell-based and competitive ligand-binding methodologies. * Evaluate antigenic equivalence and drug tolerance, applying a one-assay approach in biosimilar projects. * Perform analyses of clinical samples from immunogenicity studies (biosimilar vs. reference product). * Monitor ADA and nAb in Phase I and III clinical trials. * Interpret immunogenicity data and correlate findings with clinical safety and efficacy. * Provide technical support for regulatory dossier preparation, with focus on submissions to ANVISA. * Participate in the setup and operation of the immunogenicity laboratory. * Draft and review SOPs, analytical protocols, and technical documentation in accordance with GLP and GCP. * Conduct equipment qualification and analytical system validation. **Requirements and Qualifications** **What we seek:** * Bachelor’s degree in Pharmacy, Biomedicine, Biology, Chemistry, or related fields. * Experience in development and validation of bioanalytical methods for immunogenicity assessment. * Knowledge of ADA and nAb assays. * Experience with analytical platforms such as ELISA, MSD/ECL, SPR, and/or flow cytometry. * Clinical trial experience (Phases I–III) is considered a plus. * Familiarity with regulatory guidelines (ANVISA, FDA, EMA). * Experience with technical documentation (SOPs, protocols, reports). **Preferred Qualifications:** * Experience with biosimilars. * Work experience in GLP/GCP environments. * Participation in regulatory submissions. * Intermediate/advanced English proficiency. **Additional Information** **Work Location:** * Paulínia/SP. **What We Offer:** * Transportation Allowance; * Parking (subject to availability); * Health Insurance with no monthly premium for the employee, co-payment for exams and consultations; * Dental Plan with co-payment for the monthly premium; * Life Insurance at no cost to the employee; * Flexible Meal/Food Allowance; * Pharmacy Network; * Synvia Partnership Club (Educational, Leisure, and Cultural Institutions); * SESC Partnership; * Physical Health Program – TotalPass; * Day Off – Healthcare Professionals; * Childcare Assistance (per internal policy). We are a company with a young, innovative culture and a passion for our mission of **improving the lives of increasingly more people.** Present in Campinas, Paulínia, and São Paulo, we support the pharmaceutical industry in developing and registering new medicines and provide diagnostic services to laboratories across Brazil. **OUR WAY OF WORKING** With 20 years of experience in health and technology and over 800 employees, our culture is guided by core values: **integrity; ownership; and innovation and excellence.** We believe in the positive impact of our work through our teams and services; therefore, we encourage professional development among our employees and offer Internship, Apprenticeship, and Career Acceleration Programs. Do you identify with Synvia? Let’s improve the lives of increasingly more people—together!