Senior Formulation Scientist - Coimbra, Portugal - Bluepharma Indústria S.A

Descrição

• 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 and process 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 is performed 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.

• M.Sc. or Ph.

• 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 to develop 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.