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Job ID :
64965BR
Location :
Netherlands - Tilburg
:
Job Description
The Analytical Development Department is part of the PDS group in Tilburg and is a GMP environment according to GMP and ICH guidelines. The Analytical Development Team Leader is responsible for leading a team of analytical chemists and technicians developing highly complex analytical method and performing analytical texting lab support activities. This role ensures the team is fully utilized, following good scientific practices, adhering to standards, and meeting acceptable quality levels. The Analytical Development Team Leader serves as technical lead on project teams, and ensures customer projects are delivered on time.
  • Deliver projects on time to our customers and keep team fully utilized by keeping track progress of lab deliverables and weekly meetings with analysts of the group to provide direction and guidance;
  • Provide technical leadership on customer project teams by communicating results to customers and resolving technical issues;
  • Recommend additional development work to customers and communicate need for COS to PMs;
  • Generate protocols, methods and reports and conduct OOS and OOT investigations;
  • Coach and assist chemists and trainees to assure that they are fully trained and competent;
  • Monitor performance of team members and conduct performance appraisals;
  • Keep up to date with current regulatory requirements (ICH/FDA) guidelines and GLP/GMP guidelines and pharmacopoeia requirements (EP/USP) with respect to method validation and stability studies;
  • Ensure the Integrity of all process data generated as well as its maintenance;
  • Write or review failure reports for out of specification (OOS) test results;
  • Write problem analysis and corrective action report (PACAR);
  • Troubleshoot results and perform root cause analysis;
  • Exchange information within R&D, QC, QA, Operations and on global development projects with Patheon.
Qualifications
  • At least 5 years’ experience in the pharmaceutical or related industry;
  • Bachelor’s or Master’s degree in chemistry of analytical chemistry;
  • Good skills to conduct accurate chemical analysis with analytical equipment;
  • Proactive and result driven;
  • Strong leadership skills;
  • Current knowledge of GLP/GMP and ICH/FDA requirements and Pharmacopeia (EP/USP) requirements for analytical development and stability studies.


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