Senior Engineer - Internal Process Engineering

Amgen•Cambridge, MA

1d•Onsite

About The Position

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. 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. The Senior Engineer will operate in product and process development and/or manufacturing environments, supporting the design and execution of process characterization studies and evaluating the impact of manufacturing process parameters, production scale, equipment, and raw material changes on product quality. The role will contribute to the preparation of high-quality technical documentation, including process technology transfer documents, study reports, and technical assessments, and may support the development of relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities. You will work closely with clinical and commercial manufacturing teams to support ongoing production, new product introductions, new technology implementation, and process optimization efforts. The Senior Engineer will apply fundamental scientific principles (e.g., biochemistry, biophysics, statistics) and engineering principles (e.g., equipment, automation, chemical, mechanical engineering) to support investigations of non-conformances and the development of corrective and preventive actions. As a key technical contributor to Amgen’s commercialization and process transfer activities, the Senior Engineer will collaborate with cross-functional teams including engineering, analytical sciences, quality, regulatory, and manufacturing. This role will integrate technical knowledge and data from multiple sources to support robust process unders

Requirements

Doctorate degree
Master’s degree and 2 years of Operations or Process Development experience
Bachelor’s degree and 4 years of Operations or Process Development experience
Associate’s degree and 8 years of Operations or Process Development experience
High school diploma / GED and 10 years of Operations or Process Development experience

Nice To Haves

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

Responsibilities

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

Benefits

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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

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