Aseptic Fill/Finish Tech Leader

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Retirement and Savings Plan

Flexible work models where possible

Job summary

Amgen in Thousand Oaks, CA is seeking a Principal Engineer to lead aseptic fill/finish process development and platform maturation across biologic modalities, driving innovation and data-driven decisions.

You will collaborate across Drug Product Technologies, Quality, Regulatory, and Manufacturing to enable technology transfers, ensure GMP compliance, and advance product lifecycle from development to commercialization. Travel up to 10%.

Qualifications

• Doctorate degree with 2+ years in engineering or operations
• Masters degree with 4+ years in engineering or operations
• Bachelors degree with 6+ years in engineering or operations
• Associates degree with 10+ years in engineering or operations
• High school diploma with 12+ years in engineering or operations

Responsibilities

• Lead design and execution of process development for aseptic filling, lyophilization, and visual inspection.
• Partner with unit operation owners and subject matter experts to advance activities.
• Enable tech transfers across clinical and commercial sites.
• Collaborate to identify process improvements and share knowledge across sites.
• Analyze data using advanced statistical and analytical techniques.
• Support manufacturing via CAPA, investigations, and root-cause analysis.
• Apply AI/GenAI tools to drive automation and data analytics.
• Author guidance documents, protocols, and regulatory sections (IND/marketing).
• Provide progress reports to management on program status.

Skills

Excellent written and verbal komunik

Strong project management

Cross-functional leadership

Data-driven decision making

Education

Doctorate degree with 2 years of engineering/operations experience

Master's degree with 4 years of engineering or operations experience

Bachelor's degree with 6 years of engineering or operations experience

Associates degree with 10 years of engineering or operations experience

High school diploma/GED with 12 years of engineering or operations experience

Tools

JMP

Minitab

AI/GenAI tools

Job description

Amgen in Thousand Oaks, CA is seeking a Principal Engineer to lead aseptic fill/finish process development and platform maturation across biologic modalities, driving innovation and data-driven decisions.

You will collaborate across Drug Product Technologies, Quality, Regulatory, and Manufacturing to enable technology transfers, ensure GMP compliance, and advance product lifecycle from development to commercialization. Travel up to 10%.