Senior Formulation Scientist

2 semanas atrás

Coimbra, Coimbra, Portugal bluepharma Tempo inteiro

Principais Responsabilidades:

  • Selection of excipients and manufacturing processes to prepare prototype formulations which meet drug product requirements;
  • Design and execute preformulation 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 scaleup 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 crossfunctional 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 35years real world development of pharmaceutical dosage forms experience (maybe as part of postgraduate education) in formulation and process development and scaleup and/or clinical manufacture;
  • Familiarity with pharmaceutical industrial framework;
  • Fluency in English (oral and written);
  • Good computer skills (Microsoft Word, Excel and statisticsbased 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 problemsolving skills;
  • Close attention to details and high commitment to quality;
  • Be proactive and critical.

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