Senior MSAT Process Engineer Remote Biologics Tech Lead

BioSpace

Tustin (CA)

On-site

USD 170,000 - 200,000

Full time

14 days+

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Benefits offered by this job

Remote work options
Office locations

Job summary

Syner‑G is seeking an experienced Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years in biologics manufacturing to manage multiple monoclonal antibody technology transfer programs. You will drive cross‑functional execution from process transfer to GMP manufacturing and PPQ, partnering with MSAT leadership to improve governance and visibility.

Responsibilities include risk assessment, process validation, and collaboration with Process Development, Manufacturing, Quality, and

Qualifications

  • BS or MS in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Biotechnology, or related technical discipline preferred.
  • 10–15+ years in MSAT, process engineering, process development, technology transfer, or biologics manufacturing in biotech/pharma.
  • Experience managing multiple technology transfer programs for biologic products, preferably monoclonal antibodies.
  • Expertise in upstream/downstream biologics manufacturing, including mammalian cell culture, chromatography, filtration, UF/DF.

Responsibilities

  • Lead a portfolio of approximately 10 concurrent mAb drug substance technology transfer programs with timelines, milestones, and risks.
  • Drive technology transfer from process handoff through GMP manufacturing, PPQ execution, and commercial readiness.
  • Develop governance structures, portfolio reporting metrics, resource planning tools, and escalation pathways to improve execution visibility.
  • Provide technical leadership in monoclonal antibody manufacturing and support transfer strategy, readiness, and risk assessments.
  • Lead commissioning, qualification, startup, and operational readiness activities for technology transfer and process implementation.

Skills

MSAT leadership
process engineering
technology transfer
biologics manufacturing
mAb manufacturing

Education

BS in Chemical Engineering
MS in Biochemical Engineering

Job description

Syner‑G is seeking an experienced Staff Process Engineer / MSAT Technology Transfer Lead with 10–15+ years in biologics manufacturing to manage multiple monoclonal antibody technology transfer programs. You will drive cross‑functional execution from process transfer to GMP manufacturing and PPQ, partnering with MSAT leadership to improve governance and visibility.

Responsibilities include risk assessment, process validation, and collaboration with Process Development, Manufacturing, Quality, and

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