Principal Engineer

Job Summary

Amgen is seeking an experienced Principal Engineer - Process Development at its site in Thousand Oaks, CA and Cambridge, MA within the Pivotal Drug Substance Technologies department, The Principal Engineer will provide technical leadership for chemical process development, reaction engineering, modellling, unit operation assessment, and scale-up of active pharmaceutical ingredients in state of the art facilities. The Principal Engineer will report to the Director of the Synthetic Technologies & Engineering organization and be accountable for establishing and applying the best available technical solutions for process design as well as guiding and developing junior staff.

Basic Qualifications

Doctorate degree and 5 years of Process Development and / or Engineering experience
OR
Master's degree and 8 years of Process Development and / or Engineering experience
OR
Bachelor's degree and 10 years of Process Development and / or Engineering experience

Preferred Qualifications

• Engineering leader with excellent written and verbal communication skills, a strong desire to train and mentor less experienced engineeriing staff and to relentlessly drive innovation
• Well versed in chemical engineering fundamentals, process development, and scale up with the ability to apply these skills to a variety of chemical processes and synthetic process development areas
• Experience in working closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to enable synthetic processes and associated unit operations
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale along with strong knowledge of cGMPs
• Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, productivity and sustainability
• Strong technical aptitude for the identification, development, and implementation of novel chemical engineering technologies and data-rich experimentation methods
• Knowledgable in crystallization process development and particle engineering
• Experience with Quality by Design (QbD) and Process Analytical Technologies (PAT), applied to pharmaceutical development, Design of Experiments (DOE) and statistical analysis
• Fluency in a wide variety of analytical techniques including HPLC, GC, MS, FTIR, Raman, FBRM, particle size determination as well as experience with process systems engineering tools and programming
• Strong laboratory proficiency, command of laboratory safety practices and appropriate risk assessments
• Experience leading teams and formulating business strategies

Key Activities for the Principal Engineer include:

• Use a combination of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize robust synthetic drug substance processes
• Analyze and document the economic value of existing and proposed process solutions as well as new process platforms
• Apply chemical engineering fundamentals to unit operations needed to move a process from the lab to the plant and ultimately to commercialization
• Assess new technologies and techniques relevant to process development and engineering
• Critically evaluate new processes for identification of process improvements and the requirements necessary to prepare processes for successfull scale up and tech transfer
• Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations
• Assess and develop integrated continuous manufacturing technologies
• Develop appropriate scale-down models of unit operations to enable laboratory characterization and predictive modelling for process understanding and tech transfer

• Participate in or lead departmental teams focussed on advancing development / technology programs
• Write and review technical reports that meet high professional standards and clearly communicate complex technical recommendations or conclusions
• Conribute to regulatory documents
• Prepare original research for publication in peer-reviewed journals and presentations at scientific conferences
• Work auccessfully in a highly collaborative environment including internal laboratory teams integrated across process chemistry, chemical enginering and attribute sciences, cross functiional teams in Drug Product Technologies and with partners in the manufacturing network
• Particiapte in or lead process development initiatives with external academic researchers and pre-competitive industrial consortia
• Travel: up to 10-15% of time

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.