Third Party Products – Analytical Technology Project Leader

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Responsibilities

  1. Responsible for new product introduction at CMO’s / CLO’s coming from in-licensing partner, brand acquisitions, dual sourcing strategies or risk mitigation plans.
  2. Support the analytical transfer process from R&D to CMO’s / CLO’s, which includes supporting submission batch analysis, initial method validation and GLP document preparation.
  3. Assisting in documenting changes / updates to analytical methods and working with internal and external stakeholders to implement those changes.
  4. Provide analytical expertise to CMO’s / CLO’s.
  5. Support trouble shooting / improvement processes during method transfer as well as for commercial products when required.
  6. Additional CMO / CLO visits to investigate and remedy any analytical issues.
  7. Analytical method gap analysis, risk assessments and risk mitigation plans.
  8. Support to other analytical activities whenever there is a need.
  9. Prepare, review and approve any protocols, reports and other associated project / GLP documentation that are required to fulfil the projects or department’s needs.
  10. Ensure appropriate documentation / archival of the communication between Lotus and CMO’s / CLO’s.
  11. Provide scientific guidance and lead discussion with CMO’s / CLO’s on complex investigations and resolution of Out-Of-Specification (OOS) and Out-Of-Trend (OOT) results.
  12. Responsible for multiple analytical transfer projects, setting objectives and prioritizing activities based on business requirements. Determining budget requirements to meet organizational goals and balancing resources to ensure that business needs are met.

Requirements

  • Postgraduate in Sciences or in allied field (preferably Chemistry / Analytical Technology degree);
  • Pharma Professional with at least 10+ years of relevant experience in a similar role in the pharmaceutical industry (preferably 7+ years of experience in analytical operations / analytical technology transfer related to small molecules in solid oral dosage forms);
  • Working with international external and internal stakeholders, experienced working in cross-functional and multi-cultural environment;
  • Excellent project management skills with the ability to effectively prioritize;
  • Strong communication skills (in writing and verbally) as well as ability to influence.

Application link: https://www.jobs.bg/job/7130231