Career Opportunities: Senior Process Chemist (4306)

Bial; Porto; Presencial; EUR 40 000 - 70 000; Tempo integral

Resumo da oferta

A leading pharmaceutical company in Porto is seeking a qualified professional with a PhD in Organic Chemistry to contribute to drug candidate development. The role requires experience in the chemical industry and knowledge of GMP regulations. Responsibilities include supporting manufacturing processes and ensuring compliance with industry standards. This position promotes interdisciplinary collaboration and timely project completion.

Qualificações

• PhD in Organic Chemistry or equivalent required.
• Experience in the pharmaceutical industry is necessary.
• Knowledge of existing laws and guidelines in the pharmaceutical industry.

Responsabilidades

• Assist in the development of manufacturing routes and processes.
• Design synthetic routes paying attention to multiple aspects.
• Ensure timely preparation of technical reports and documents.

Conhecimentos

PhD in Organic Chemistry or equivalent

Experience in Chemical Industry

Knowledge of GMP for API manufacturing

Strong communication skills

Team player with flexibility

Formação académica

PhD in Organic Chemistry

Ferramentas

Design of Experiments (DoE)

IT and IS systems in the field

Descrição da oferta de emprego

Requisition ID4306-Posted -Portugal-Porto

Join Our Mission to Improve Lives Worldwide
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.

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;
• 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.

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).

Create Your Path@Bial
“Working at a company like Bial is a privilege. Our size and structure allow us to have end-to-end knowledge and involvement across the entire R&D process. It is the real meaning of "from bench to bedside".”
Teófilo Vasconcelos (Director, Pharmaceutical Sciences)