Senior Process Chemist

2 semanas atrás

Porto, 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 crossfunctionally with Other Departments of the Company.

PREFERENTIAL REQUIREMENTS AND FACTORS:

  • PhD in Organic Chemistry or equivalent, at least 4 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 trackrecord and thorough crossfunctional 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 scaleup and manufacturing in the fine Chemical Industry (preferred).

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