Responsibilities
* Collect information required for the analytical target profile from project stakeholders (analytical lead, project manager, product owner, etc.).
* Propose and test candidate analytical techniques potentially able to meet expected needs.
* Develop robust and efficient analytical methods by aQBD using classical LC-UV methods with minimal assistance, applying modern statistical approaches to support validation.
* Collect data from development, make decisions, and propose solutions based on results. Prepare support and present development status in technical team review meetings.
* Ensure complex technical data are reported with scientific excellence and communicate analytical activity outcomes to the team, supervisor, or customer.
* Understand and comply with regulatory requirements pertaining to analytical method performance.
* Contribute to or collaborate on analytical method validation, co-validation, and transfer activities internally or with external laboratories.
* Design complex study designs and write associated quality documents (protocols, reports, procedures).
* Document results in laboratory notebooks according to established GDP procedures.
* Advise supervision and customers when facing issues and propose options to meet timelines or reset timelines.
* Participate in method comparability and equivalence studies to support the analytical method lifecycle.
* Interact with cross-functional teams of analytical experts across internal and external labs and suppliers.
* Identify risks, issues, and opportunities and communicate them to supervisor and customer.
* Collaborate on investigations of complex analytical issues related to atypical or out-of-specification results and instrumentation or methodology concerns.
Qualifications
* Holds a master’s degree in chemistry/analytical chemistry or a related field.
* More than 4 years of relevant experience.
* Strong knowledge of various analytical techniques, especially Liquid Chromatography (LC-UV) with significant experience in development, validation/verification/transfer, and troubleshooting.
* Understanding of interactions with Formulation, Process Development, Regulatory Affairs, and QA.
* Solid knowledge of compendial and other applicable regulations.
* Fluent English communication skills; French is a plus.
* Basic project management skills.
* Demonstrated ownership, critical thinking, and adaptability.
* Ability to operate in certified environments.
* Willingness to learn new analytical techniques.
* Knowledge of new analytical strategies (ICH Q14, QbD).
Additional Information
* Full-time (40 hours/week), Monday – Friday.
* Job location: Braine-l’Alleud.
* Permanent contract with flexible working hours.
* Meal vouchers and supplementary benefits as part of compensation package.
* DKV hospitalization insurance.
* Additional paid days off and a company well-being program.
* Collaborative international work environment with team events and development opportunities.
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