Pharmaceutical Scientist

4 meses atrás

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 product-related 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 cross-functionally 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;
- Hands-on 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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