Pharmaceutical Scientist

1 semana atrás


Porto, Porto, Portugal Bial Tempo inteiro

Role:

Key responsibilities:

  • Run characterization studies of drug substance and drug product, making the best use of the available technologies;
  • Design, implement and execute laboratorial development activities towards innovative formulations;
  • Interpret in silico/ in vitro/ in vivo data on drug performance and establish paths for its improvement;
  • Plan and execute scale up and technology transfer activities of developed formulations;
  • Manufacture of clinical trial materials and oversight of clinical trial supplies used in clinical trials;
  • Analyze results of studies and prepare reports for both corporate records and regulatory frames;
  • Prepare Characterization and drug productrelated CMC sections of IND/IMPD and MAA regulatory submissions, ensuring that those deliverables are met and aligned with technical content;
  • Participate in brainstorming activities and contribute with new proposals and ideas;
  • Participate in the identification and acquisition of new manufacturing/ characterization technologies;
  • Collaborate with internal and external partners, to strategically drive innovation and promote scientific excellence;
  • When required, work crossfunctionally with other Departments of the Company;
  • Work with third parties, being accountable for their technical oversight;
  • Assist in the planning and management of pharmaceutical research efforts.

Requirements:

  • 3 years minimum experience in Pharmaceutical Development, in an Industrial or Academic environment;
  • Handson experience with drug delivery systems and solid oral dosage forms, as well as with data analysis and interpretation (pharmaceutical, biopharmaceutical, PK);
  • Experience with characterization analytical techniques (HPLC, DSC, TG, XRPD) and data evaluation;
  • Strong knowledge of the EU-GMP and relevant Guidelines;
  • Fluency in English (written and spoken);
  • Knowledge in the most common IT systems and software in the field;
  • High intellectual and autonomy level with strong organization skills are important for the position;
  • Results oriented and focused on goals;
  • Good team player, with good communication and interpersonal relationship skills are valued.


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