Analytical Sciences Manager

3 weken geleden

Amsterdam, Noord-Holland, Nederland Santen Voltijd

At Santen, we are seeking a highly skilled Analytical Sciences Manager to join our team. In this role, you will be responsible for providing front-line expert support for all analytical test methods specific issues to the assigned product manufactured and tested at CDMOs and/or testing at Third Party laboratories. Your primary objective will be to ensure the execution of on-time product release, continuously improving product quality and analytical procedures, performed in compliance to cGxP, SOPs and applicable international guidelines, regulations, and norms.

Key responsibilities include:

  • Site Product Manufacturing and Release Support: Provide front-line support to the product manufacturing process analytics, release testing and working with the QC teams (internal sites), or in close collaboration with CDMO Analytical Expert counterparts, focusing on the testing methods for each batch, their release on time and in compliance with the batch and analytical procedures instructions and quality requirements.
  • Qualification & Validation: Support the execution of analytical methods qualifications and/or validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shop floor (internally) or CDMO manufacturing team (externally) to ensure accurate execution.
  • Technical improvement execution: Execute analytical methods improvements and support methods development for additional product and/or process related characterization studies.
  • Primary packaging closure assessment during changes: Drive the qualification and/or validation of primary packaging materials testing methods including the design of container suitability studies for the assigned product(s).
  • Assure consistency of Analytical Testing Procedures: Ensure that all critical and significant parameters are within written Instruction (e.g., Testing procedures, Validation Plan), sufficient and appropriate for the product.
  • Deviation, Out of Expectation, Out of Specification, complaint handling: Lead and/or support the GPS organization with all product and process related analytical investigations and deviations including complaints, Out of Expectation, Out of Specification, in partnership with internal / external site analytical teams.
  • Annual Product Reviews and Product Quality Reviews: Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations.
  • Training: Own the Training Curriculum for his/her Job Profile and provide the necessary training and support to new associates joining this position.
  • Audit support: Maintain their work at "inspection readiness level" and to provide the necessary support in any internal or external audit.

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