Senior Process Development Engineer Scale-Up & Transfer

Amgen SA; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Sr Engineer to author technical reports, lead risk assessments, and contribute to regulatory documents through tech transfer and commercialization. The role is based in Cambridge, MA or Thousand Oaks, CA and involves up to 20% travel.

The candidate will design and optimize robust processes, evaluate novel chemistries, and support scale-up across departments, ensuring compliance with regulatory and quality standards.

Qualifications

• Doctorate or approved combination of advanced degree with engineering experience.
• Experience with technology transfer, scale-up and manufacturing of synthetic molecules in regulated environments.
• Knowledge of regulatory and cGMP requirements.
• Strong communication and presentation skills.

Responsibilities

• Author, review and approve process documentation for transfer and commercialization.
• Lead or support regulatory and quality activities such as NDAs and process verification.
• Design, optimize, and deploy process models for kinetics, mass transfer, distillations and hydrodynamics.
• Provide on-the-floor support for scale-up and rapid problem solving.
• Collaborate with chemists, formulation scientists, and analytical chemists to interpret data.

Skills

Strong communication skills

Leadership ability

Problem solving

Education

Doctorate degree

Master's + 2 years Engineering Experience

Bachelor's + 4 years Engineering Experience

Associate's + 8 years Engineering Experience

High school diploma / GED + 10 years Engineering Experience

Tools

Analytical techniques (HPLC, GC, MS, NMR, FTIR)

HPAPI processing familiarity

Job description

Amgen is seeking a Sr Engineer to author technical reports, lead risk assessments, and contribute to regulatory documents through tech transfer and commercialization. The role is based in Cambridge, MA or Thousand Oaks, CA and involves up to 20% travel.

The candidate will design and optimize robust processes, evaluate novel chemistries, and support scale-up across departments, ensuring compliance with regulatory and quality standards.