Senior Engineer - Pivotal and Commercial Synthetic

Senior Engineer

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 represent the Drug Substance Technologies (DST) organization as a technical leader for Amgens synthetic commercial product(s). As the DST representative you will be responsible to collaborate with the product delivery team(s) to work with the manufacturing organization(s) to ensure drug substance supply and resolve challenges, identifying and implementing process improvements, and authoring regulatory documents in support of the product lifecycle. In addition to the commercial leadership, you will have the opportunity to lead the process optimization, characterization, and technical transfer of Amgens synthetic drug substance processes across all phases of development.

The Sr. Engineer is accountable for establishing and applying the best available technical solutions for development and commercial manufacturing. The qualified candidate will be well versed in chemical engineering fundamentals, 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 process development, reaction engineering, unit operation assessment, 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 introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturingoperationsmeet process requirements, where necessary work with the sites(s) to introduce new equipment and supervise manufacturing. Also utilizes their experience to provide in-plant support during key production activities.

Responsibilities include but are not limited to:

• Executions of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize robust synthetic processes.
• Critically evaluate new processes for identification of process improvements and requirements necessary to prepare processes for scale up and tech transfer.
• Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Analyze and document the economic value of existing, proposed process solutions and new process concepts.
• Assess and develop continuous processing technologies to prepare processes for scale up and tech transfer.
• 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 aligned with tech transfer timeline are established and achieved.
• Apply standard 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 necessary for scale up and tech transfer.
• 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 support to commercial projects to support supply demand, ensure highest quality standards and guarantee patient safety.
• Provide on the floor support to ensure successful scale up and rapid problem solving and decision making.
• Lead or represent department as subject matter expert (SME) 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, unit operations and life cycle phase of commercial products.

Basic Qualifications

Any of the followingin a chemical engineering, chemistry, or related scientific and engineering field of study:

• Doctorate Degree
• Masters degree and 3 years of Engineering or Operations experience
• Bachelors degree and 5 years of Engineering or Operations experience
• Associate's degree and 10 years of Engineering or Operations experience
• High School Diploma and 12 years of Engineering or Operations experience

Preferred Qualifications

• 5+ years of engineering experience driving deliverables for pharmaceutical processes development and manufacturing
• Experience in developing and executing 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 utilizing first principle models (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 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
• Fluency in German and/or Italian a plus

Join Us

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.

Amgen requires all staff in the United States and Puerto Rico 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.