Hybrid Process Engineer II — Biopharma Tech Transfer

Genetix Biotherapeutics

Somerville (MA)

Hybrid

USD 90,000 - 116,000

Full time

6 days ago
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Benefits offered by this job

Annual bonus
Comprehensive benefits

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking a Process Engineer II to join the MSAT team. You will help enable seamless technology transfer and provide technical support for our autologous cell therapy manufacturing platform in a cGMP environment.

You will collaborate with Technical Development, Quality, and our CDMO partners to drive process improvements, execute tech transfer projects, and ensure robust documentation and training.

Qualifications

  • Bachelor’s or Master’s degree in Engineering or Life Sciences.
  • 3–5 years in biopharma manufacturing, MSAT or CMC roles.
  • Experience in a cGMP manufacturing environment with tech transfer.
  • Strong communication and leadership for cross-functional teams.
  • Experience with autologous cell therapies preferred.
  • Regulatory familiarity in biotechnology industry.

Responsibilities

  • Act as the technical expert for GMP production at CDMO partners.
  • Conduct investigations using root cause analysis to prevent recurrence.
  • Develop process trending and CPP/PPQ programs to keep processes controlled.
  • Lead cross-functional tech transfer teams and track progress.
  • Prepare and review technical documentation, sampling plans, risk assessments.
  • Provide hands-on support for tech transfer and GMP runs as PiP.
  • Oversee PPQ runs and engineering/process qualification efforts.
  • Drive continuous improvement and operational excellence.

Skills

Root cause analysis
Statistical analysis
Cross-functional leadership
Process transfer
Project management
cGMP experience

Education

Bachelor’s or Master’s degree

Job description

Genetix Biotherapeutics in Somerville, MA is seeking a Process Engineer II to join the MSAT team. You will help enable seamless technology transfer and provide technical support for our autologous cell therapy manufacturing platform in a cGMP environment.

You will collaborate with Technical Development, Quality, and our CDMO partners to drive process improvements, execute tech transfer projects, and ensure robust documentation and training.

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