Senior Process Engineer, Tech Transfer & Scale-Up

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen seeks a Sr Engineer in Thousand Oaks, CA (or Cambridge, MA) to lead process modeling, risk assessments and technology transfer activities. You will author regulatory documents and coordinate with cross-functional teams to enable robust scale-up and successful commercialization.

The role requires advanced engineering experience, strong communication skills, and a track record in bioprocessing or chemical manufacturing within cGMP environments.

Qualifications

• PhD or MS in chemical engineering or related field.
• Bachelors with 4+ years of engineering experience.
• Associates with 8+ years of engineering experience.

Responsibilities

• Author technical reports and risk assessments for tech transfer.
• Lead scale-up activities and support manufacturing transfer.
• Design, optimize, and deploy process models for kinetics, mass transfer, separations, distillations, and hydrodynamics.
• Evaluate economic value and environmental impact of processes.
• Prepare process documentation for validation and commercialization.
• Collaborate with chemists, formulation scientists and analytics.
• Provide on-the-floor support to troubleshoot and ensure smooth tech transfer.

Skills

Process modeling

Tech transfer

Regulatory documentation

Statistical analysis

Design of experiments

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

HPLC

GC

NMR

Process simulation software

Job description

Amgen seeks a Sr Engineer in Thousand Oaks, CA (or Cambridge, MA) to lead process modeling, risk assessments and technology transfer activities. You will author regulatory documents and coordinate with cross-functional teams to enable robust scale-up and successful commercialization.

The role requires advanced engineering experience, strong communication skills, and a track record in bioprocessing or chemical manufacturing within cGMP environments.