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Let’s do this. Let’s change the world. In this vital role you will join Amgen’s Drug Product Process Engineering team within the Drug Product Technologies organization. Reporting to the Principal Engineer or Sr. Manager of Process Engineering, this role will support the development, implementation, and continuous improvement of drug product processes across Amgen’s parenteral portfolio. The Senior Engineer will contribute technical expertise to support evolving business needs, industry trends, and stakeholder priorities. This role will be based in Thousand Oaks, CA or Cambridge, MA to ensure effective technology transfer support to our commercial drug product manufacturing plants. Some US and international travel may be required to support Amgen’s global drug product network.
Job Responsibility:
Lead or support commercial technology transfers by executing make-a-batch assessments to determine facility fit, designing and executing offline and on-site characterization studies, authoring high-quality process transfer documentation, providing on-site support, and evaluating potential product impacts due to process, scale, equipment, and raw material changes
Work collaboratively with a team of process scientists and engineers to design, implement, and document process development and technology transfer activities, generating primary data packages while applying expertise in aseptic processing, equipment, automation, and unit operation characterization
Serve as a drug product technical specialist providing solutions for parenteral manufacturing across unit operations including, but not limited to, formulation, sterile filtration, filling, capping, lyophilization, and visual inspection
Support continuous improvement in drug product development and manufacturing through application of first principles in process engineering and by leveraging data-driven approaches, including advanced data analytics, modeling, and emerging AI-enabled tools to enhance process understanding and robustness
Support technology transfers for pipeline and commercial products and contribute to lifecycle management activities across a range of parenteral modalities
Deliver clear progress reports and technical presentations to management and project teams to communicate status, risks, and key findings, and escalate issues or unresolved technical challenges through appropriate governance channels
Participate in global cross-functional teams, working effectively within a highly matrixed environment to advance programs through clinical manufacturing and commercialization
Build and sustain strong relationships with drug product development teams and manufacturing partners to ensure alignment between program needs, process requirements, and site capabilities
Apply fundamental scientific (biochemistry, biophysics, statistics) and engineering principles (equipment, automation, chemical, mechanical) to support process characterization, scale-up, and troubleshooting activities
Explore and implement opportunities to utilize digital and AI-enabled approaches for process
Requirements:
Doctorate degree
Or Master's degree and 2 years of Operations or Process Development experience
Or Bachelor's degree and 4 years of Operations or Process Development experience
Or Associate's degree and 8 years of Operations or Process Development experience
Or High school diploma / GED and 10 years of Operations or Process Development experience
Nice to have:
M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
Familiarity with aseptic processing, drug product manufacturing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
Knowledge of bringing new products to market, across various dosage forms and delivery systems
Knowledge of associated GMP/Device documentation and regulatory filings
Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations
The ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterization
Familiarity with the application of AI-enabled tools to support process characterization, process monitoring, and data-driven decision making in drug product development and manufacturing
Experience in a matrix team environment, in particular interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Interpersonal, communication and facilitation skills necessary to represent functional position, and forge consensus among competing client interests while ensuring objectives are met
Ability to learn and act on dynamic information at a rapid pace
Ability to travel domestically and internationally up to 25% of the time
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan