SP l São Paulo
Efetivo (CLT)
Biólogo
Bioquímico
Farmacêutico
Químico
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.
