Senior Director - Head of Process Engineering; Synthetic Drug Substance Process Development

Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)

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.

What You Will Do

Let's do this. Let's change the world. Would you like to lead a highly motivated team of process development experts and professionals to positively impact patients' lives? Amgen is seeking a Senior Director to serve as our Head of Process Engineering within the Drug Substance Technologies – Synthetics (DSTS) organization. In this role, the Senior Director will be a member of the DSTS Leadership Team and be accountable to drive technical and strategic solutions for the development, characterization, technology transfer, and lifecycle management of synthetic and hybrid drug substance manufacturing processes for our early- and late-phase clinical and commercial portfolios.

In this on-site role – located in either Cambridge, MA or Thousand Oaks, CA – you will lead and develop a global, multi‑site organization of 30+ scientists and engineers, provide strategic oversite to ensure program success, and foster a culture of safety, quality, compliance, and technical excellence. In addition, you will represent the DSTS organization in our cross functional collaborations to ensure the successful implementation and performance of our clinical/commercial drugs substance manufacturing processes.

Key Responsibilities:

• Lead a global organization with accountability for the capability of our small molecule/hybrid process engineering team, talent development, succession planning, performance management, and fostering a culture of innovation, collaboration, and operational excellence.
• Provide strategic oversight for the advancement of our synthetic & hybrid portfolio from early-phase clinical through commercial advancement and lifecycle management.
• Establish and implement improved engineering business and technology platforms from early-phase through commercial process development, process characterization, lifecycle management, and technology transfer.
• Strengthen the technical capabilities and innovative practices across the engineering organization.
• Author and review global regulatory filings (IND/INDa/MAA) and responses to regulatory agency questions.
• Foster a culture of safety, quality, and compliance while ensuring adherence to standard operating procedures.
• Recruit, develop, and retain a high-performing and diverse team.
• Manage portfolio prioritization, resource allocation, and budget.
• Partner with manufacturing and external network collaborators to enable successful process technology transfer, validation and clinical/commercial supply.
• Engage directly with the leadership and technical teams of our external partners and contract development & manufacturing organization (CDMOs).
• Drive ideation, development, and deployment of innovative and differentiating technologies that decrease development time and create more robustness and cost-effective processes.
• Identify process improvement opportunities to increase robustness and reduce cost over the lifecycle of commercial drug substance processes.
• Contribute to Amgen's…