Clinical research scientist II – São Paulo/SP

Responsabilidades

• Plan and manage PE/BWV/CDP studies conducted by a hired CRO.
• Work with the CRO responsible for study execution to ensure that all deliverables are received as per the agreed upon timelines and current legal requirements.
• Conduct audits and monitoring visits of CROs (may include travel).
• Evaluate technical documents related to product pharmaceutical R&D and BD dossiers according to BR requirements and the strategy of PE/BWV/CDP studies to determine the scope of said studies.
• Actively participate in project team meetings and provide technical support for generic product development and new products when necessary.
• Purchase materials for PE/BWV/CDP studies and organize shipment to the hired CRO according to service agreement requests (main materials: analytical standards of API/impurities, chromatography materials, and other consumables for pharmaceutical analysis).
• Perform development of material suppliers when necessary.
• Manage the process of hiring a CRO to conduct PE/BWV/CDP studies and manage the service agreement.
• Provide technical support to CROs during method transfer and analytical activities of PE/BWV/CDP studies, acting as a focal point in technical discussions with product R&D.
• Analyze and interpret results generated during these studies.
• Approve final PE/BWV/CDP reports and provide deficiency support to Regulatory Affairs on said reports when required.

Requisitos

• Extensive experience in pharmaceutical equivalence (PE), with at least 5 years of analytical method development/validation, and knowledge of Brazilian requirements for PE and analytical method validation.
• Previous knowledge or experience in bioequivalence (BE) is preferable.
• Ability to plan, organize, coordinate, and manage tasks efficiently.
• Strong knowledge and experience in physicochemical analyses, instrumental analysis (chromatography techniques, mass spectrometry, among others), and bioanalyses.
• Solid knowledge and experience in analytical method development, analytical method validation, and bioanalytical method validation.
• Solid knowledge of chemistry applied to pharmaceutical development related to generic products and pharmaceutical research.
• Strong knowledge of Quality Assurance applied to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
• Experience in process, project, and people management applied to analytical R&D, Quality Control, Quality Assurance, Pharmaceutical Equivalence, Bioequivalence, and Clinical Research within the pharmaceutical industry.
• Solid knowledge of MS Office pack and SAP System (including Ariba System).
• University degree in Pharmacy, Chemistry, Biology, Health and Science, or related fields.
• Good communication skills and ability to work collaboratively within a team environment on both a local and global level.
• Ability to evaluate complex technical information and work with various global R&D teams and local CROs to conduct PE/BWV/CDP studies effectively.
• English language proficiency.
• Advanced Spanish (nice to have).

Benefícios

• Support designed to help you thrive in and out of work from day one.
• Generous annual leave.
• Reward plans.
• Flexible working schedules (dependent on role).
• Access to tailored health support.
• Meaningful ways to give back to the community.
• Access to a wide range of career development possibilities, from learning programs and short-term projects to opportunities for internal growth through Twist.

Marcado como: Análises Físico-Químicas, Bioequivalência, Controle de Qualidade, Cromatografia, Espectrometria, Indústria Farmacêutica, Pesquisa Clínica