Senior Biotech CMC Integration Project Lead

Initial Therapeutics, Inc.; Thousand Oaks (CA); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Annual bonus program

Stock-based incentives

Flexible work model

Job summary

Amgen is seeking a Senior Project Manager in CMC Integration to drive cross-functional program delivery across Process Development. You will coordinate timelines for Pre-Pivotal, Pivotal, and Lifecycle stages, partnering with technical leads to ensure alignment with clinical and commercial goals.

You will manage PD teams, support governance reviews, and push for decisions that keep programs on track, while applying lessons learned to improve processes and outcomes across projects.

Qualifications

• Requires doctorate with 2+ years PM experience or advanced degrees with commensurate PM experience.
• Experience leading cross-functional teams in Process Development or related PD functions.
• Ability to build and maintain project timelines for Pre-Pivotal, Pivotal and Lifecycle stages.
• Strong communication to support governance reviews and risk reporting.

Responsibilities

• Partner with Process Development leaders to build timelines aligned with clinical and commercial targets.
• Ensure active, aligned communication in governance meetings.
• Drive effective decision making and clear reporting.
• Establish and manage collaboration sites; track delivery and repositories for PD deliverables.
• Report product metrics with Business Analysis and Performance teams.
• Incorporate lessons learned and best practices across projects.
• Support Business Process improvements including the Commercialization Office alignment.
• Provide risk analysis and project reporting.
• Lead and coach a team of PMs across products and projects.

Skills

Cross-functional collaboration

Interpersonal communication

Critical thinking

Project coordination

Education

Doctorate

Masters

Bachelor's

Associates

High school diploma / GED

Tools

MS Project

Excel

SharePoint

Job description

Amgen is seeking a Senior Project Manager in CMC Integration to drive cross-functional program delivery across Process Development. You will coordinate timelines for Pre-Pivotal, Pivotal, and Lifecycle stages, partnering with technical leads to ensure alignment with clinical and commercial goals.

You will manage PD teams, support governance reviews, and push for decisions that keep programs on track, while applying lessons learned to improve processes and outcomes across projects.