Research Associate III - ICP-OES/MS Lead
Baxter International
Braine-l'Alleud, Belgium
In this role, you will be responsible for planning and supervising ICP-OES/MS analytical method development and optimization on raw materials and finished products, with support from technical SMEs. You will collect relevant information related to product specifications and propose appropriate analytical methods, define and propose validation/transfer designs, ensure testing follow-up, and communicate results.
What you'll be doing:
- Manage a team of analytical SMEs on ICP-OES/MS techniques;
- Plan and supervise method development and optimization on raw materials and finished products;
- Collect relevant product information and propose appropriate analytical methods;
- Define and propose validation/transfer design, ensure testing follow-up and communication of results;
- Order required materials and equipment for studies;
- Write/review comprehensive protocols and reports in English;
- Lead method evaluation, validation, or transfer (Baxter or CRO);
- Provide advice and assistance to team members;
- Interpret experimental data and present conclusions to project leader and management;
- Work with applicable software and statistical tools;
- Review data and results critically for compliance with protocol and procedures;
- Lead investigation on failed acceptance criteria;
- Adhere to quality system requirements, GMP, GDP and EHS guidelines;
- Create and update equipment and analytical procedures;
- Independently make decisions and propose activities for potential questions from authorities;
- Contribute to innovative ideas for improvement.
What you'll bring:
- Master or PhD or strong equivalent expertise in relevant Sciences Domain;
- 5 years of experience in analytical chemistry, method development/Validation;
- Knowledge of new analytical strategies as described in ICH Q14 (QbD);
- Strong technical knowledge in ICP-MS/ICP-OES, with experience in managing method development, validation, transfer, and investigation;
- In-depth understanding of GxP and related regulations and guidances;
- Previous experience in project management, with knowledge of interactions with other fields (formulation, regulatory affairs, process development, quality control, manufacturing, etc.);
- Able to make critical decisions, solve issues, and develop solutions with "out of the box" thinking;
- Able to lead a small team, mentor junior associates, and communicate sophisticated information effectively;
- Strong written and oral communication skills, proficiency in English.
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