Senior Engineer - Process Development

em, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer - Process Development
What you will do

Let's do this. Let's change the world. In this vital role you will be accountable to advance industry leading solutions for the design, development, and deployment of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization. The qualified candidate will be proficient in chemical engineering fundamentals, process development & characterization, and process safety & scale-up for synthetic processes using both batch and continuous technologies. The Senior Engineer will provide technical leadership for reaction engineering, unit operation assessment, and technology development &

implementation.

The Senior Engineer will partner with or lead a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for the intended phase of technology transfer, which will include process introduction, clinical

manufacturing, validation and commercial manufacturing. While working with our manufacturing teams to determine if equipment and manufacturing operations meet process requirements and will collaborate with the production site(s) to introduce new equipment and capabilities.

The Senior Engineer will be responsible for authoring technical reports, leading risk assessments, and contributing to regulatory documents through all phases of technology transfer and commercialization.

Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.

• Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements vital to ensure safe and successful scale-up and tech transfer.
• Design, optimize, and deploy process models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.
• Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
• Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline, such that key achievements are established and achieved.
• Apply standard and sophisticated engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
• Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in order to critically evaluate chemical processes for identification of process improvements and requirements vital for scale up and tech transfer.
• Author, review and/or approve of process documentation needed for process validation and commercialization activities.
• Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.
• Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.
• Lead or represent department as domain expert for process risk analysis.
• Work closely with process development chemists, formulation scientists, and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering experience; OR

• Associate's degree and 8 years of Engineering experience; Or

• Bachelor's degree and 4 years of Engineering experience; Or

• Master's degree and 2 years of Engineering experience; Or

• Doctorate degree

Preferred Qualifications:

• 5+ years of engineering experience getting results related to synthetic process development and chemical manufacturing.

• Experience in developing and implementing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, and productivity.

• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.

• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.

• Experience building and applying first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.

• Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.

• Experience using data science and/or sophisticated statistical analysis to address processing issues and evaluate opportunities for process improvements.

• Proficient understanding of regulatory and cGMP requirements

• Command of lab and plant operations and associated safety practices

• Strong communication and presentation skills

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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 to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Salary Range
119,195.00 USD - 147,867.00 USD