Associate Director, Drug Product Process & Lifecycle

BioSpace; Thousand Oaks (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Amgen in Thousand Oaks, CA, seeks Associate Director to lead Drug Product Commercialization and lifecycle management. You will oversee drug product programs as DPTL, and mentor a scientific team, driving transfers, process improvements, and regulatory submissions.

This role requires strong cross-functional leadership, global collaboration, and ability to travel up to 10%. You will develop guidelines, reports, and respond to regulatory questions while ensuring supply of commercial products.

Qualifications

• Doctorate degree or master's/ bachelor’s/ associate qualifications with extensive experience in engineering or science.
• Minimum 3 years directly managing people and/or leadership experience leading teams, projects, programs, or resource allocation.

Responsibilities

• Lead drug product development programs as DPTL and drive commercialization lifecycle activities.
• Coach a scientific team and oversee late-stage product development, tech transfer, and process improvements.
• Support clinical and commercial fill/finish operations through capability analysis and root cause investigations.
• Drive process engineering innovations and apply first principles for robust drug product development.
• Lead cross-functional global teams to influence change and build strong relationships.
• Author/review guidelines, protocols, reports, regulatory submissions, and regulatory responses.
• Deliver progress updates to management on status, needs and future directions.
• Travel domestically and internationally up to 10% as needed.

Skills

People leadership

Cross-functional leadership

Team leadership

Project management

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Job description

Amgen in Thousand Oaks, CA, seeks Associate Director to lead Drug Product Commercialization and lifecycle management. You will oversee drug product programs as DPTL, and mentor a scientific team, driving transfers, process improvements, and regulatory submissions.

This role requires strong cross-functional leadership, global collaboration, and ability to travel up to 10%. You will develop guidelines, reports, and respond to regulatory questions while ensuring supply of commercial products.