Principal Engineer - Synthetic Process Development - Amgen

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 award-winning 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.

Principal Engineer - Synthetic Process Development

Lets do this. Lets change the world. In this vital role you will be accountable to drive lab-based technical solutions and provide overall guidance and leadership for the development, characterization, and technology transfer of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization and lifecycle management. To achieve this goal, the Principal Engineer will partner multi-functionally with Amgens chemistry, analytical, drug product, quality, safety, and operations teams to ensure successful transfer, implementation, and validation of Amgens drug substance processes at internal and external clinical and commercial manufacturing facilities.

• Contributes to and leads program deliverables for the advancement of our synthetic & hybrid portfolio through all stages of commercial process development and lifecycle management
• Accountable for establishing and implementing engineering standards for commercial process development and process characterization
• Drives excellence in execution for technical transfers of innovative DS processes
• Adheres to and drives all standards for safety, quality, and compliance
• Enhances performance through the continuous advance of technical capabilities and technical and strategic competencies within the engineering team
• Lab-based contributions and general leadership of our drug substance processes leveraging a ChemE foundation and practical knowledge of relevant unit operations.
• Process Development: supporting the development of chemical processes and positioning drug substance processes for commercialization success by designing and performing experimental plans; leading, implementing and deploying process-analytical tools (PAT) to enable process understanding and design; process simulation using an array of process modeling and engineering tools; and process characterization.
• Expert Analysis: including process and technology review analysis and improvement identification; assessment of applicable new technologies and techniques.
• Contribute to increasing the effectiveness and efficiency of the department by contributing towards improvements of guidelines, procedures, practices, standards and multi-functional business interfaces and processes.
• Contributes effectively as an individual and also routinely leads process engineering and drug substance development teams
• Identifies resource needs and establishes priority for projected activities
• Facilitates cohesiveness and builds team spirit as we work toward a common goal to develop industry-leading medicines that serve patients
• Communicates effectively with others, demonstrating compassion and the principles of people-centered leadership

Domestic and International Travel: up to 20%

We are all different, yet we all use our unique contributions to serve patients. The Principal Engineer professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Engineering experience OR
• Associates degree and 10 years of Engineering experience OR
• Bachelors degree and 6 years of Engineering experience OR
• Masters degree and 4 years of Engineering experience OR
• Doctorate degree and 2 years of Engineering experience

Preferred Qualifications:

• 8+ years of relevant chemical engineering experience driving individual and group deliverables related to synthetic process development and chemical manufacturing in pharmaceutical development.
• Experience in developing and implementing experimental plans to evaluate and develop processes to achieve optimum cost, adaptability, safety, sustainability, and efficiency.
• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules and hybrid modalities in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.
• 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.
• Proficiency in lab-based implementation of and data interpretation for wide variety of analytical methods, process analytical tools, and solid-state characterization methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Evaluate early- and late-stage chemical processes to establish and implement lab-based pre-requisites to enable of bench/kilo laboratory experiments to ensure successful scale-up to manufacturing scales.
• Apply chemical engineering fundamentals 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, including leading on the floor support and rapid problem solving and decision making.
• Apply engineering principles and statistical analysis, including design of experiments, evaluate chemical processes for potential process improvements to enable successful scale-up and transfer to manufacturing sites.
• Lead and handle authoring of user documentation required for process characterization design plans, failure-mode risk assessments for science-based determination of parameter and test criticality, engineering scale-up evaluations, process validation preparedness across all stages of development.
• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
• Practical experience using data science and/or advanced statistical analysis to tackle 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
• Excellent communication and presentation skills and motivation to lead teams of engineers and chemists through different stages of chemical process development in lab-based execution
• Domestic and International Travel: up to 20%

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, 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 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

for a career that defies imagination

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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.