Senior MSAT Leader, Biologics Process Development

amgen

Singapore

On-site

SGD 180,000 - 240,000

Full time

14 days+
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Job summary

Amgen is seeking a Senior Manager Process Development (MSAT) to lead biologics tech transfer and ongoing cGMP production support for commercial processes. The role encompasses scale-up, validation, troubleshooting, and cross-functional collaboration to meet quality, schedule, and cost objectives.

The successful candidate will manage a Process Development team, drive technology evaluations, and support regulatory filings and inspections, contributing to drug substance leadership and overall site

Qualifications

  • PhD or equivalent with biologics PD or scale-up experience.
  • 8+ years in biotech processes in regulated (cGMP) environments with 2+ years of management.
  • Strong cell culture or purification process expertise.
  • Experience with tech transfer, validation, troubleshooting and investigations.
  • Excellent communication with diverse stakeholders; regulatory familiarity.

Responsibilities

  • Lead biologics technology transfer, process validation and new tech evaluation/implementation.
  • Lead site activities for process optimization, complex investigations, and lifecycle management.
  • Manage a team in Process Development and key projects across functions.
  • Collaborate with cross-functional and network teams to resolve complex challenges.
  • Deliver site goals on schedule and within cost, maintaining safety and compliance.
  • Support regulatory filings, audits, inspections, and other CMC activities.
  • Serve on the DST extended leadership team to advance capabilities.

Skills

Biologics PD
cGMP expertise
Technology transfer
Team leadership
Process validation
Regulatory filings
Statistical methods

Education

Doctorate in Biotech
Master's in Biotech
Bachelor's in Biotech

Job description

Amgen is seeking a Senior Manager Process Development (MSAT) to lead biologics tech transfer and ongoing cGMP production support for commercial processes. The role encompasses scale-up, validation, troubleshooting, and cross-functional collaboration to meet quality, schedule, and cost objectives.

The successful candidate will manage a Process Development team, drive technology evaluations, and support regulatory filings and inspections, contributing to drug substance leadership and overall site

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