Head of Process Engineering, Synthetic Drug Substance

Amgen

Thousand Oaks (CA)

On-site

USD 280,000 - 450,000

Full time

6 days ago

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Benefits offered by this job

Retirement and Savings Plan

Medical, dental & vision coverage

Stock-based long-term incentives

Flexible work models

Job summary

Amgen seeks a Senior Director – Head of Process Engineering within Drug Substance Technologies (DSTS) to lead a global team focused on synthetic and hybrid drug substance processes. The role demands strategic vision, regulatory experience, and talent development across multiple sites, including Thousand Oaks, CA.

You will drive technology transfer, process characterization, and lifecycle management, collaborating with CDMOs and manufacturing partners to ensure robust, compliant, scalable

Qualifications

Requires doctorate or master’s with extensive process development leadership.
Experience managing 20+ staff and large programs.
Fluency in cGMP operations, tech transfer, scale-up, and commercialization.

Responsibilities

Lead a global organization of 30+ scientists and engineers.
Provide strategic oversight from early-phase to commercial processes.
Oversee technology transfer, lifecycle management, and regulatory filings.

Skills

People management

Strategic leadership

Cross-functional collaboration

Regulatory knowledge

Process engineering expertise

Education

PhD in Chemical Engineering or related field

MS in chemical engineering or related

Bachelor’s degree with extensive experience

Tools

IND/INDa/MAA filings

Job description

You will drive technology transfer, process characterization, and lifecycle management, collaborating with CDMOs and manufacturing partners to ensure robust, compliant, scalable

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