Research Scientist I - Analytical Lead

Baxter International

Braine-l'Alleud, Belgium

We are seeking an Analytical Lead to form part of a group of analytical experts responsible for the continuity, quality, compliance, and profitability of Nutrition Solutions on-market products, in our site on Braine L'Alleud. As the Analytical Lead for sophisticated and/or large-size projects, you will support the execution of product changes in compliance with international regulations and quality standards by working with cross-functional teams and/or SMEs to ensure problem-solving, decision-making, and change execution within project timelines.

As an Analytical Lead, your responsibilities will include:

Developing an Analytical Plan (AP)/Analytical Business Strategy (ABS) for complex and/or large size projects, using appropriate project management tools to keep an updated status and follow-up of analytical activities.
Building strong partnerships with internal analytical teams by setting clear analytical expectations, routinely providing advice and assistance, and proposing options to meet timelines or provide new timelines in case of troubleshooting.
Making independent decisions on projects based on previous experience and proposing activities to reply pro-actively to potential questions from authorities.
Planning experimental designs and/or technical tasks that may not be well defined, have multiple variables, and require advanced techniques within negotiated deadlines.
Providing necessary support to analytical method development, as a Study Director, defining and proposing test design (sample size, tests to perform), ensuring testing follow-up and communication of results.
Leading evaluation, validation, or transfer of analytical methods according to study protocol, interpreting experimental data, and communicating conclusions to the project leader and management.
Critically reviewing and documenting development/validation results, writing comprehensive protocols and reports, creating and updating analytical procedures, and leading investigations on failed acceptance criteria.
Supporting receiving sites in method transfer by sharing development and technical knowledge, collaborating with the method development/validation team for this purpose.
Initiating, leading, or supporting projects and change controls aligned with capacity expansion, SNC’s, or other design/process changes for on-market products.
Adhering to quality system requirements, GMP and GDP standards, and EHS guidelines.
Working with global teams across various functions to maintain business continuity.
Contributing to efforts beyond own scope of responsibilities to ensure project achievements are met.
Critically reviewing ELN and other experimental data to ensure compliance with analytical methods, global and local procedures (GDP, quality system, etc.), and scientific correctness.

What you'll bring:

B.Sc. in a scientific field with 10+ years experience, M.Sc. with 5+ years experience or PhD with 1+ year experience.
Relevant experience in analytical chemistry, method development/Validation, and analytical leadership.
Knowledge of new analytical strategies as described in ICH Q14 and QbD.
Strong technical knowledge on analytical techniques with experience in development, validation, and investigation of analytical methods.
Experience in project management and understanding of interactions with other subject areas (formulation, regulatory affairs, process development, quality control, manufacturing).
Good knowledge of ICH guidelines and submission process.
Relevant laboratory/technical, writing, and computer skills.
Ability to solve problems independently, develop solutions, and make recommendations.
In-depth knowledge of GxP and related regulations and guidance.
Able to work in a team environment and demonstrate an inclusive attitude.
Takes ownership and leadership for getting the job done.
Strong written and oral communication skills.
Can manage conflicts and influence others.
Autonomous, organized, precise, and flexible to changes.
Scientific rigor and honesty.
Trackwise experience is an asset.
Fluency in English.