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Principal Scientist, Drug Product Development to Launch

Bristol Myers Squibb UK & Ireland · Dublin

جديد
🇬🇧 English
Technology transfer Continuous process verification Operational Excellence (OPEX) Process improvement Annual Product Quality Review (APQR)

وصف الوظيفة

About the role

This position provides technical leadership for external manufacturing organizations and contract manufacturing organizations (CMOs) in drug product development and launch. The Principal Scientist will drive technology transfer, ensure robust process performance, and support continuous supply security for BMS products.

Key responsibilities

  • Lead or contribute to technical support for external manufacturing and internal sites.
  • Manage technology transfer to CMOs, ensuring robust, scalable processes.
  • Support CMO/vendor selection, prepare technical packages, and evaluate RFIs/RFPs.
  • Oversee regulatory activities related to product changes.
  • Provide ongoing operational support to CMOs, including metrics review, investigations, change control, and APQR.
  • Implement Operational Excellence (OPEX) initiatives and continuous process verification.
  • Represent MS&T on Virtual Plant Team (VPT) and cross‑functional project teams.
  • Collaborate with supply relationship managers and brand teams to mitigate supply risks.

Required profile

  • Experience leading technology transfer and supporting commercial manufacturing in a pharmaceutical environment.
  • Strong knowledge of external manufacturing models, CMO governance, and supply continuity strategies.
  • Proven ability to work with regulatory, quality, and supply chain stakeholders.
  • Excellent problem‑solving skills and ability to drive continuous improvement.

Required skills

  • Technology transfer
  • Continuous process verification
  • Operational Excellence (OPEX)
  • Process improvement
  • Regulatory change control
  • Annual Product Quality Review (APQR)
  • Robustness monitoring plan development

What we offer

  • Competitive benefits and flexible work programs.
  • Opportunities for professional growth within a global biopharma leader.
  • Collaborative environment focused on innovative drug development.

Questions fréquentes

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Bristol Myers Squibb UK & Ireland

Dublin