Senior Formulation Scientist

4 semanas atrás


Coimbra, Coimbra, Portugal Bluepharma Tempo inteiro
Job Title: Senior Formulation Scientist

We are seeking a highly skilled Senior Formulation Scientist to join our team at Bluepharma. As a key member of our Formulation Development function, you will be responsible for the development of pharmaceutical dosage forms and processes.

Key Responsibilities:
  • Selection of excipients and manufacturing processes to prepare prototype formulations that meet drug product requirements;
  • Design and execution of pre-formulation studies to support Product Development work;
  • Design and execution of formulation screening experiments using different types of components, technologies, and statistical software;
  • Design and execution of formulation development studies within an R&D environment;
  • Drafting of protocols and production batch records;
  • Conducting technical risk assessments to identify risks and mitigation opportunities to enable successful development and scale-up to GMP Manufacturing Environment;
  • Conducting formulation and process scale-up activities to GMP environment;
  • Documentation and reporting of results of all experiments in a manner consistent with department practices and governing policies;
  • Generation, collection, interpretation of data sets, and authoring of reports and presentations to share product knowledge and project progress with clients;
  • Overseeing GMP production and providing support as required;
  • Providing scientific support in all aspects of formulation and drug product development;
  • Working closely with Clients, Partners, or CROs in developing formulations and processes;
  • Presentation of data and active participation in discussions on development activities, experimental design, etc.;
  • Participation in project updates for client's technical calls;
  • Authoring and reviewing of protocols and development reports that will support Drug Product Dossier submission for global filings;
  • Identification and troubleshooting of process challenges during GMP batch execution and proposal of strategies for formulation and process improvements;
  • Writing of SOPs, protocols, and reports as required;
  • Ensuring 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;
  • Providing technical support to the Business Development team as required;
  • Representation of the Formulation Development function in cross-functional project teams and during client project meetings as required;
  • Performance of other related duties as required.
Requirements:
  • M.Sc. or Ph.D. in a relevant scientific discipline such as Pharmaceutical, Chemical, Engineering, or other related fields;
  • Experience of at least 3-5 years in 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;
  • Proactivity and critical thinking.

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