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Scientist II, Global Technical Operations

AbbVie · Singapore

New
Senior 🇬🇧 English
Biologics DS operations Process validation Tech transfer CMC GxP

Job description

About the role

AbbVie is looking for a Scientist II in Global Technical Operations in Singapore. You will act as a technical expert who independently investigates, develops and optimises methods and techniques for critical project needs, supporting both laboratory and commercial manufacturing of antibodies (ADCs). You will apply scientific and engineering principles and statistical process design and analysis to build robust antibody manufacturing processes, and work as a lead scientist evaluating scientific and regulatory advances.

Key responsibilities

  • Resolve key project hurdles and support late-stage and commercial biologics manufacturing, tech transfer, process validation, investigations, troubleshooting, scale-up and continuous improvement
  • Work in a diverse team to support and troubleshoot current commercial manufacturing
  • Support or lead new product introductions at AbbVie sites or third-party manufacturers, ensuring successful tech transfer, scale-up and validation
  • Support CMC life-cycle management and post-approval continued process validation for commercial antibody processes
  • Collaborate with process development on late-stage tech transfers, scale-up and validation during the transition to commercial manufacturing
  • Support product investigations and non-conformances, identify root causes and make scientific and quality recommendations
  • Author and review CMC sections of submissions and support agency inspections, inquiries and audits
  • Represent the MSAT antibody group in CMC program teams and maintain strong internal and external relationships
  • Adhere to corporate standards including code of conduct, safety, GxP, controlled substances and animal care where applicable

Required profile

  • B.Sc. with 7+ years of experience, or M.Sc. with 5+ years of relevant experience
  • Demonstrated experience with biologics DS operations
  • Ability to lead and influence cross-functional teams
  • Effective writer and communicator of research or regulatory materials
  • Strong analytical skills
  • Willingness to travel up to 10%

Questions fréquentes

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Source : ats:smartrecruiters

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Published 10 hours ago

Expires 1 month from now

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AbbVie

Singapore