Senior Manager - Drug Substance Technology & Engineering

Career Category

Engineering

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas
-Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager - Drug Substance Technology & Engineering

What you will do

Let's do this. Let's change the world!

Amgen is seeking a Senior Manager to join the Drug Substance Technology & Engineering (DSTE) team at our Thousand Oaks, California site. In this onsite leadership role, you will oversee downstream purification manufacturing support unit operations supporting both clinical and commercial biologics drug substance. You will lead a team of downstream process engineers and play a key role in early phase technology transfer and the manufacturing execution, process optimization, and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

This is an exciting opportunity for a strong technical and people leader who thrives in a highly collaborative, fast-paced, and innovation-driven environment. In addition to supporting commercial and pipeline programs, you will help shape cross-functional initiatives that advance technology, process performance, and business outcomes.

Location:

Thousand Oaks, CA

Travel:
Up to 10% domestic and international travel

KEY RESPONSIBILITIES:

* Support the development, scale-up, tech transfer and manufacturing execution of cGMP clinical and commercial downstream purification processes including, but not limited to harvest, clarification, chromatography (Protein A, AEX, CEX, etc), viral filtration, UF/DF, and sterile filtration.

* Apply engineering principles and statistical analysis in order to:

* Identify, develop and implement downstream process improvements into the manufacturing facility.

* Resolve technical issues observed during scale-up and/or manufacturing execution of purification processes.

* Manage escalation and on the floor support as required to achieve successful scale-up and manufacturing objectives.

* Interface with process development teams to ensure processes are robust and are designed to deliver all quality attributes and enable manufacturing success.

* Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation and Supply Chain to drive continuous improvements into our business processes.

* Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management

* Ensure safety and compliance of process development activities

* Collaborate with other site-functions and network drug substance teams in delivering plant goals

* Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives

* Ensure manufacturing operations are aligned with the registered process

* Provide support for regulatory filing, inspection, and other CMC activities

* Serve as member of the ATO DSTE leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities

Supervising Others / Team Experience

* Create multi-year technical strategies for advancing business performance.

* Ensures that safe practices are followed.

* Provides mentoring and expertise to staff on the downstream team

* Motivates, develops, and coaches staff while promoting team collaboration

* Applies effective management practices in the direction and development of others

Leadership and Influence

* Identifies and negotiates resources and develops timelines for project activities.

* Collaborates within the department and interdepartmentally.

* Provides scientific and technical leadership

* Ensure department staff are adequately developed and trained

* Provides adequate feedback through coaching and effective performance appraisal and development planning

* Initiates and encourages scientific collaboration with groups outside the department

* Manage project resources (material, labor, time, etc.), and elevate relevant issues to project lead and line-management

* Build and…