Process Chemist

2 meses atrás

Porto, Portugal Bial Tempo inteiro

**MISSION**:
Develop practical, safe, environmentally friendly and cost effective processes for the synthesis of novel compounds selected to progress from research/discovery to a larger scale, meeting the defined objectives in terms of safety, quality, regulatory and costs.

**MAIN ATTRIBUTIONS AND RESPONSIBILITIES**:

- Stay abreast of the intermediates and raw material suppliers in conjunction with QA with attention to the scientific, economy, logistic and regulatory aspects;
- Use design of experiments (DoE) to change multiple variables simultaneously and identify acceptable ranges for operational parameters defining the relevant design space by QbD approach;
- Review major documents that support filing such as Small Molecules rationale, (synthesis and process)criticality, PAR justification, spiking report, impurity assessment report, etc.;
- Report progress on Process Research Development to line manager;
- Use a variety of analytical methods to monitor reaction processes;
- Align the activities in compliance to all the Bial policies and the existing laws for aspects concerning, quality, environment, safety and the respective timelines;
- Provide regulatory support to DS CMC section preparation;
- Mentor and provide support to junior members of the team;
- Work cross-functionally with Other Departments of the Company.

**PREFERENTIAL REQUIREMENTS AND FACTORS**:

- PhD in Organic Chemistry or equivalent, with at least 2 years of experience in Chemical Industry within the pharmaceutical industry;
- Good knowledge of existing laws and guidelines in the pharmaceutical industry and specific aspects concerning, costs, quality, environment and safety;
- Have a thorough understanding of the requirements of the entire API development process within a pharmaceutical company.
- Knowledge and understanding of all the GMP for API manufacturing and the laws and regulatory aspects related to the business (REACH, ICH, FDA guidelines);
- Knowledge and practical understanding of ICH M7 guideline on genotoxic impurities.
- Proven track-record and thorough cross-functional knowledge of relevant Active Pharmaceutical Ingredient (API) production activities;
- Fluency in English (written and spoken);
- Motivated with a strong and dynamic personal drive to learn;
- Good team player, with upgraded proactivity, responsibility, flexibility and availability;
- Ability to set priorities and work under tight deadlines;
- Solid communication and interpersonal relationship skills.
- Availability to travel to support/supervise the receiving part during and after the technology transfer operations;
- Chemical Engineering Knowledge (preferred);
- High knowledge of the most common IT and IS systems and software in the field (preferred);
- Experience in Process Research scale-up and manufacturing in the fine Chemical Industry (preferred).

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