Process Chemist

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Process Chemist

Bial

Porto, Portugal

The Impact You’ll Make

Assist in the identification and development of manufacturing routes and processes to guarantee timely support to BIAL's Drug Candidates add meet long term objectives in terms of costs and supply;
Design synthetic routes with suitable intermediates and raw material suppliers with attention to the scientific, process safety, 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 Quality by Design (QbD) approach;
Evaluate and recommend with support of the Process Chemistry Manager the generation and protection of IP around routes processes for the manufacturing drug candidates and for providing assistance to the Legal Department in the preparation of the required documents for adequately protecting the generated IP;
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;
Ensure the proper and timely preparation of technical reports (monthly reports), manuscripts, and other documents. Assists the technology transfer process required for the primary manufacturing of Bial Drug Candidates and commercial products;
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;
Comply with the Quality, Environmental, R&D, Health and Safety Policies, Standards and Procedures;
Collaborate in all department activities as needed.

What You’ll Bring

PhD in Organic Chemistry or equivalent;
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;
Experience in Process Research scale-up and manufacturing in the fine Chemical Industry (preferred);
Chemical Engineering Knowledge (preferred);
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;
High knowledge of the most common IT and IS systems and software in the field (preferred).