Director Process Development - Purification Process Engineering

Director, Process Development – Purification Process Engineering

Join Amgen and lead the Purification Process Engineering function within the Process Development organization. In this role you will provide technical guidance for commercial Drug Substance operations at a high‑mix, multi‑product manufacturing facility. Responsibilities include technical transfer and scale‑up of processes, deployment of novel manufacturing technologies, and troubleshooting biologics manufacturing processes.

The successful candidate will serve as the primary process development point of contact with Manufacturing and Quality leadership. You will manage process engineering deliverables such as new process introductions, technology implementations, Process Performance Qualification (PPQ), and ongoing monitoring of drug substance production. Your entrepreneurial approach will drive innovation and plant efficiency through process, technology, and capacity improvement opportunities, ensuring outputs are safe, compliant, and aligned with plant performance goals.

• Lead and provide subject‑matter expertise in bioprocess purification disciplines, including chromatography and filtration operations.
• Support process scale‑up and technology transfer to production facilities, partnering closely with development teams.
• Lead a high‑performing team focused on engagement and achieving team potential.
• Lead cross‑functional teams to resolve complex technical problems while meeting quality, schedule, and cost objectives.
• Act as a member of the Drug Substance Technology extended leadership team, applying network thinking to advance process development.
• Engage with manufacturing and process development networks to assess technology and improve facility capacity and capability.

We seek a leader with a blend of technical expertise and managerial experience.

• Bachelor’s degree + 10 years of Process Development, Engineering, or Manufacturing experience; OR
• Master’s degree + 8 years of Process Development, Engineering, or Manufacturing experience; OR
• Doctorate + 4 years of Process Development, Engineering, or Manufacturing experience.

In addition, you must have at least 4 years of experience directly managing people and/or leading teams, projects, or programs.

• MS degree in Chemistry, Biochemistry, Chemical Engineering, or a related technological field.
• 10+ years of pharmaceutical/biopharmaceutical process development or support experience, with current knowledge of cGMP and global regulatory expectations.
• Ability to provide scientific and engineering expertise to multi‑functional teams in manufacturing, quality, and supply chain.
• Proficiency in compiling and statistically analyzing data, drawing conclusions, and presenting to multi‑functional audiences and senior management.
• Detailed understanding of the Process Validation lifecycle for biologics (Design, PPQ, CPV).
• Understanding of quality attributes of large molecules and associated analytical methods.
• Strong leadership, negotiation, and customer‑expectation management skills.

Amgen offers a comprehensive Total Rewards Plan, competitive benefits, and development opportunities that support your professional and personal growth. While the base salary is posted, actual pay may vary based on experience and qualifications.

Amgen does not have a specific Final date to receive applications; we will continue accepting applications until we select a candidate. Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation throughout the application and interview process.