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Method Development & Validation Specialist
Braine-l'Alleud, Wallonia, BelgiumPosted 1 months ago
Full-timeonsiteMid-Senior Level
Job Description
- Collect information required for the analytical target profile from Project (analytical lead, project manager, product owner…).
- Propose and test candidate analytical techniques potentially able to meet expected needs.
- Develop robust & efficient analytical methods by aQBD using classical LC-UV method with no/limited assistance utilizing modern & state‑of‑the‑art statistical approaches to bring them to successful validation.
- Collect data from development and take decisions / propose solutions based on obtained results. Prepare support and present development status in technical team review meetings.
- Assure that complex technical data are reported with scientific excellence and communicate the outcome of the analytical activity to team/supervisor/customer.
- Understand and master all regulatory requirements pertaining to analytical method performance.
- Contribute and/or collaborate to analytical method validation/co-validation/transfer both internally or external labs.
- 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 customer when facing issues and propose options to meet timeline/define new timeline.
- Participate in method comparability/equivalence studies to enable continuation of the analytical method lifecycle.
- Interact with cross‑functional teams of analytical experts with internal/external labs/suppliers.
- Identify risks, issues and opportunities and communicate to supervisor and customer.
- Collaborate to investigations in complex analytical issues corresponding to atypical or out‑of‑specification/trend test results and instrumentation/methodology issues.
- Holds a master’s degree in chemistry/Analytical chemistry or a similar field.
- We are looking for candidates who have more than 4 years of experience.
- Strong technical knowledge of various analytical techniques, especially Liquid Chromatography (LC-UV) with significant experience in development validation/verification/transfer and troubleshooting.
- Understanding of interactions with other disciplines: Formulation, Process Development, Regulatory Affairs, QA.
- Strong knowledge of compendial and other applicable regulations.
- Fluent communication skills in English; French is nice to have.
- Basic project management skills.
- The candidate must show Ownership, critical mindset and out of the box thinking.
- Ability to operate in certified environments.
- Eagerness to learn new analytical techniques.
- Knowledge of new analytical strategies (ICH Q14, QbD…).
- A full-time (40hours/week) Monday – Friday job.
- Job location: Braine l'alleud
- A Permanent contract with flexible working hours.
- Work in a fast-growing international organization.
- Meal Vouchers 8 Euro/Working Day.
- Eco-Cheques +/- 250 Euro/Year.
- DKV Hospitalization insurance.
- Additional 12 ADV days.
- A company well-being program targeting both mental and physical well-being.
- A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment.
- Personal development through learning on the job and additional trainings.