.Principais Responsabilidades Selection of excipients and manufacturing processes to prepare prototype formulations which meet drug product requirements; Design and execute pre-formulation studies to support Product Development work; Design and execute formulation screening experiments using different types of components, technologies and using different statistical software; Design and execute formulation development studies within an R&D environment; Draft protocols and production batch records; Conduct technical risk assessment to identify risks and mitigation opportunities to enable successful development and scale-up to GMP Manufacturing Environment; Conduct formulation andprocess scale up activities to GMP environment; Document and report result of all experiments in a manner consistent with department practices and governing policies, as applicable; Generate, collect, interpret data sets and author reports and presentations, to share product knowledge and project progress with clients; Oversee GMP production and provide support as required; Provide scientific support in all aspects of formulation and drug product development; Work closely with Clients, Partners or CRO's in developing formulations and processes; Present data and actively participate in discussions on development activities, experimental design, etc; Participate in project updates for client's technical calls; Author and review protocols and development reports which will support Drug Product Dossier submission for global filings; Identify and troubleshoot process challenges during GMP batch execution and propose strategies for formulation and process improvements; Write SOPs, protocols and reports as required; Ensure that all work isperformed within established key workflows and/or regulations as described by SOPs, corporate policies and external regulatory guidance, as well as in compliance with the applicable cGMPs and GLPs; Give technical support to the Business Development team as required; Represent the Formulation Development function in cross-functional project teams and during client project meetings as required; Perform other related duties as required. Requisitos M.Sc. or Ph.D. in relevant scientific discipline as Pharmaceutical, Chemical, Engineering or other related; Experience at least 3-5years real world development of pharmaceutical dosage forms experience (maybe as part of postgraduate education) in formulation and process development and scale-up and/or clinical manufacture; Familiarity with pharmaceutical industrial framework; Fluency in English (oral and written); Good computer skills (Microsoft Word, Excel and statistics-based programs); Strong time management and organization skills; Communication skills todevelop good working relationships and to work effectively in a team environment; Strong analytical and problem-solving skills; Close attention to details and high commitment to quality; Be proactive and critical
