Senior Engineer - Process Development

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Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll 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

Lets do this! Lets 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 & scaleup 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 multifunctional 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 labbased of bench and kilogramscale 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 scaleup 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 multifunctional 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 scaleup.

• 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 inorder 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 nonconformances process performance qualification and continued process verification.

• Provide onthefloor support to ensure successful scaleup and facilitate rapid problem solving and decisionmaking.

• 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 Senior Engineer professional we seek is a dynamic teammate with these qualifications.

Basic Qualifications:

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

• Associates degree and 8 years of Engineering or Operations experience OR

• Bachelors degree and 4 years of Engineering or Operations experience OR

• Masters degree and 2 years of Engineering or Operations 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 scaleup and manufacturing of synthetic molecules in a regulated environment. This includes technical support for nonconformance 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 firstprinciple models (e.g. reaction kinetics mass transfer separations distillations isolations drying and hydrodynamics) with proficiency across several modeling platforms.

• Knowledge of analytical techniques and solidstate 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 wellbeing. From our competitive benefits to our collaborative culture well 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.

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