Sr Engineer, Pivotal and Commercial Synthetics - Crystallization

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Would you like to work with a highly motivated team of process science professionals to positively impact patients lives? Amgen is seeking a Senior Engineer in the Pivotal and Commercial Synthetics team to be responsible for leading the crystallization process optimization, characterization, and technical transfer of Amgens synthetic drug substance processes across all phases of development and commercialization.

The Sr. Engineer is accountable for establishing and applying the best available technical solutions for development. The qualified candidate will be well versed in chemical engineering fundamentals, crystallization process development, and scale up with the ability to apply their skills to a variety of synthetic process development areas using both batch and continuous technologies. The Sr. Engineer will provide technical leadership for crystallization process development, reaction engineering, unit operation assessment, and technology development.

The Sr. Engineer works with 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 its intended phase of technology transfer: process design, tech transfer, validation, and clinical/commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, and where necessary work with the sites(s) to introduce new equipment. Also applies their experience to provide in-plant support during key production activities.

The Sr. Engineer will be responsible to author technical reports and regulatory documents.

Location: Thousand Oaks, CA.

Domestic and International Travel: up to 20%

Responsibilities include but are not limited to:

• Develop robust, safe, scalable and efficient crystallization processes for various intermediates and APIs to deliver the desired physical and chemical properties that can be transferred to manufacturing facility.

• Analyze data to understand crystallization kinetic and thermodynamic factors impacting API isolation and impurity rejection, filtration, and drying.

• Collaborate with Pre-Pivotal Drug Substance, Drug Product and Formulation groups to identify desired solid-state attributes for API process development.

• Partner with Amgens internal and contract manufacturing sites to ensure successful execution of crystallization processes and represent the function as a domain expert for non-routine problem solving.

• Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding of crystallization process performance.

• Apply solubility platforms and models to identify optimal solvent systems for crystallization development.

• Executions of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize batch and continuous crystallization processes.

• Characterization of physical properties and downstream performance from crystallization processes.

• Analyze and document the economic value of proposed process solutions and new process concepts.

• Author, review and/or approve of process documentation needed for process validation and commercialization.

• 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 rapid problem solving and decision making.

• Lead or represent department as SME for process risk analysis.

• Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved crystallization process understanding.

Basic Qualifications

• Doctorate Degree OR MS degree and 3 years of Engineering or Operations experience OR Bachelors degree and 5 years of Engineering or Operations experience OR Associates degree and 10 years of Engineering or Operations experience OR High school diploma / GED and 12 years of Engineering or Operations experience

Preferred Qualifications

• 5+ years of engineering experience driving work for pharmaceutical processes development and manufacturing

• Experience in developing crystallization processes with a firm understanding of thermodynamics and kinetics of crystallization processes using analytical tools such as Particle Track, Easy Viewer, React IR and Raman probes.

• Hands on experience of analytical and solid-state characterization techniques with proficiency in a wide variety of methods including XRPD, DSC, TGA, Microcopy (hot stage), Crystal 16, HPLC, GC, NMR, KF, FTIR, LOD, TOC, particle size determination, etc.

• Experience in developing and carrying out 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 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 using first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms

• Experience using data science and/or advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements

• Possess strong understanding of regulatory and cGMP requirements

• Command of lab and plant operations and associated safety practices

• Strong communication and presentation skills

• Must be able to work efficiently in an interdisciplinary team environment

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, 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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.