Amgen - Thousand Oaks, CA
posted 3 months ago
At Amgen, our shared mission—to serve patients—drives all that we do. The Principal Engineer will join Amgen's Drug Product Process Engineering team in the Drug Product Technologies organization. This role is pivotal in managing a team of commercial process validation subject matter experts to ensure execution excellence of commercial technology transfers into the drug product manufacturing facility in Thousand Oaks, California. The Principal Engineer will work closely with the Associate Director of ATO Process Engineering and will be responsible for contributing to the strategic direction of the group based on emerging business needs, industry trends, and feedback from key collaborators. This position may require some US or international travel to support Amgen's drug product network. The Principal Engineer will be accountable for successfully implementing all site process development activities to enable commercial tech transfers of parenteral drug products to Amgen's manufacturing facility. This includes managing and supervising a team of tech transfer leads, ensuring the transferability of off-line characterization studies, designing and implementing on-site characterization studies and process validation runs, and authoring high-quality technical documents and regulatory files. The role also involves being a key contributor to regulatory filings and supporting PAI and GMP inspections in the plant. Building and sustaining excellent relationships with partners across various teams such as drug product teams, NPI, QA, Supply Chain, Process Development, and manufacturing is essential to ensure alignment between program needs and site capabilities. The Principal Engineer will also be responsible for developing and maturing business processes to manage the tech transfer portfolio effectively, ensuring successful project completion and increasing team productivity. In addition, the Principal Engineer will provide process development expertise for commercial drug product processing, support commercial drug product manufacturing operations, and engage with the internal DP manufacturing network to guide the development and adoption of multi-site practices and process improvements. The role requires delivering progress reports and presentations, guiding and mentoring staff, and demonstrating a deep understanding of Amgen's drug product and primary container platforms.