R&D Method Development & Validation Specialist

Our client, a leading pharmaceutical organization, is seeking an R&D Method Development & Validation Specialist to support their analytical operations. This role focuses on developing and validating robust analytical methods using state-of-the-art statistical approaches to ensure scientific excellence.

• Develop robust and efficient analytical methods using advanced statistical approaches for successful validation.
• Design complex study designs and author associated quality documentation including protocols, reports, and procedures.
• Collect and analyze development data to propose technical solutions and present status updates in technical review meetings.
• Coordinate analytical method validation, co-validation, and transfer activities both internally and with external laboratories.
• Collaborate on investigations for complex analytical issues such as atypical results, OOS, and OOT.
• Maintain laboratory records and documentation according to established GDP procedures and regulatory requirements.

• You have a Master in Science in Analytical Chemistry, Organic Chemistry, Biochemistry, or Pharmaceutical Science.
• You bring 5+ years of relevant experience in the pharmaceutical industry within R&D or manufacturing.
• You possess advanced technical knowledge of analytical techniques, with significant expertise in Liquid Chromatography development, validation, and troubleshooting.
• You have strong knowledge of compendial regulations and modern analytical strategies such as ICH Q14 and QbD.
• You're able to apply problem-solving methodologies such as Six Sigma within a GMP certified environment.
• You have strategic thinking abilities and a proactive, solution-oriented mindset.
• You are fluent in English.

Nice to Haves

• Basic project management skills.
• Understanding of interactions between formulation, process development, and QA.
• Eagerness to learn new analytical techniques.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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