The successful candidate will operate in a fast-paced, matrixed environment, collaborating across Drug Product Technologies, Quality, Regulatory, and Manufacturing Operations. They will be accountable for advancing technical solutions, driving innovation, and improving operational efficiency across the network. A successful candidate will be self-motivated, able to manage complex work packages, and excel at influencing across teams. They will also bring a forward-looking mindset—staying ahead of trends and technology to shape the future of drug product development at Amgen.
This position requires up to 10% travel to domestic and international sites.
Key Responsibilities
Lead the design and execution of process development for aseptic filling, lyophilization, and visual inspection.
Apply comprehensive knowledge of process and product commercialization to develop and standardize tools that improve business-process efficiency and harmonization, including study designs, prior-knowledge assessments, lessons learned, and protocol and report templates.
Partner with unit operation owners and subject matter experts to advance these activities.
Partner with cross-functional subject matter experts across the drug product manufacturing network to execute filling, lyophilization, and visual inspection characterization and recipe development, enabling technology transfers and new product introductions across clinical and commercial manufacturing sites.
Collaborate across functions to identify and implement process improvements, provide technical support, and facilitate knowledge sharing across sites.
Analyze data using advanced statistical and analytical techniques and statistical software.
Support clinical and commercial fill/finish manufacturing, as needed, through process capability analysis, troubleshooting, root-cause analysis, and product impact assessments for nonconformance investigations and process changes or improvements.
Apply and advance in silico modeling tools.
Author and review guidance documents, technical protocols and reports, product impact assessments, and regulatory sections supporting IND and marketing application submissions.
Provide progress reports and presentations that keep management informed and engaged on program status, advancement, and future functional needs.
Periodically support the authorship of manuscripts and technical articles, departmental workshops, and evaluations of offline capabilities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
