Senior Engineer — Biopharma Process Development & Transfer

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Senior Engineer to provide technical leadership in parenteral drug product process design and commercialization. You will lead offline characterization activities and collaborate with global technology transfer teams to transfer processes to clinical/commercial fill-finish lines, aiming to reduce onsite characterization work.

The role involves developing business cases for pilot plant capabilities, supporting development of computational models, and enabling rapid, robust

Qualifications

• Doctorate degree or
• Master's degree and 2 years of engineering experience or
• Bachelor's degree and 4 years of engineering experience or
• Associate's degree and 8 years of engineering experience or
• High School Diploma/GED and 10 years of engineering experience.

Responsibilities

• Operate and troubleshoot filling equipment for characterization, studies, and material generation to support the Amgen network.
• Design, implement and document technical data packages related to drug product process design, development and characterization.
• Meticulous review of protocols and study design to streamline execution and ensure successful implementation.
• Support development of models and other data analytics tools for rapid process development and tech transfer.
• Drive innovations in drug product process characterization and reduce pilot plant and GMP line time for successful technology transfers and NPIs.

Skills

Process characterization

Biopharmaceuticals

Scale-up

Problem solving

Technical leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High School Diploma/GED

Job description

Amgen is seeking a Senior Engineer to provide technical leadership in parenteral drug product process design and commercialization. You will lead offline characterization activities and collaborate with global technology transfer teams to transfer processes to clinical/commercial fill-finish lines, aiming to reduce onsite characterization work.

The role involves developing business cases for pilot plant capabilities, supporting development of computational models, and enabling rapid, robust