Senior Manager Process Development (MSAT)

Amgen

  • Singapore
  • Permanent
  • Full-time
  • 1 month ago
Career Category Process DevelopmentJob DescriptionSenior Manager Process DevelopmentAmgen Singapore ManufacturingHOW MIGHT YOU DEFY IMAGINATION?Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Manager (Process Development) in Amgen Singapore Manufacturing.LiveWhat you will doThe Senior Manager will apply process engineering subject matter expertise to support technology transfer and ongoing cGMP production of commercial protein biologics processes. Scope of work could include:
  • Lead projects focused on biologics technology transfer, process validation, and new technology evaluation/implementation.
  • Lead site activities for process optimization, complex investigation, and product life cycle management.
  • Lead teams with direct reports in Process Development group, manage key projects or business processes across functions.
  • Collaborate with cross-functional teams and network drug substance teams to resolve complex challenges by applying advanced technical principles and concepts for troubleshooting.
  • Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
  • Ensure safety and compliance of process development and/ or manufacturing activities.
  • Provide support for regulatory filings, audits and inspections, and other CMC activities.
  • Serve as member of the Drug Substance Technology (DST) extended leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities.
WinWhat we expect of youQualifications
  • Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience OR
  • Master’s degree and 6 years of biologics process development or commercial-scale technical support experience OR
  • Bachelor’s degree and 8 years of biologics process development or commercial-scale technical support experience
  • 8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) and 2+ years of management experience.
  • Strong and in-depth expertise in cell culture and/or purification processes.
  • Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation.
  • Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders.
  • Knowledgeable in regulatory filings and inspections.
  • Familiarity in operational aspects of commercial biopharma manufacturing.
  • Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing.
Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..

Amgen