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Sr. Manager Contract Manufacturing Specialists Team Lead

amgen · Singapore

New
Senior 🇬🇧 English
cGMP CAPA validation

Job description

About the role

Amgen is looking for a Senior Manager Contract Manufacturing Specialists Team Lead to oversee a team of professionals and guide them in contract manufacturing operations. The role covers manufacturing oversight, site performance monitoring, project management and technology transfers, and business process improvement including AI implementation.

Key responsibilities

  • Oversee manufacturing operations: budget development, monitoring and reporting, and inputs to contracts, confidentiality agreements, scope of work agreements, requests for pricing and supply agreements.
  • Own and coach staff on managing deviations, CAPA, CAPA EV and complex change control records.
  • Report contract site performance metrics, identify improvement opportunities, analyse data and metrics, and standardise performance tools; oversee procurement and payment of invoices and take part in team meetings with contract sites.
  • Lead department-wide projects from conception to close-out, manage timelines, highlight risks and escalate issues to the right level.
  • Lead continuous improvement initiatives and implement practical AI-enabled solutions that streamline processes, reduce manual effort and strengthen data-driven decisions.

Required profile

  • Doctorate with 2 years of directly related experience, or Master's with 6 years, or Bachelor's with 8 years of directly related experience.
  • 8+ years of proven experience in protein, API, drug substance, drug product or packaging manufacturing.
  • 8+ years of working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
  • 5+ years in a people leadership and team management role.
  • Experience leading cross-functional, matrixed teams, with strong writing, presentation and interpersonal skills.
  • Ability to handle ambiguity and complexity and to multi-task while delivering quality results.
  • Travel as needed to support business requirements; selection is subject to meeting the medical requirements of the role.

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Source : ats:workday

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Published 3 hours ago

Expires 1 month from now

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amgen

Singapore