Senior Engineer, Process Development

About the role

Amgen is hiring a Senior Engineer, Process Development to author technical reports, lead risk assessments and contribute to regulatory documents throughout technology transfer and commercialization. The position is based in either Cambridge, MA or Thousand Oaks, CA, with domestic and international travel of up to 20%. The role works with process development chemists, formulation scientists and analytical chemists.

Key responsibilities

• Execute bench and kilogram-scale experiments and process modeling and simulation to design and optimize synthetic and hybrid processes.
• Evaluate novel chemical processes for scale-up and technology transfer, and model reaction kinetics, mass transfer, separations, distillations, isolations, drying and hydrodynamics.
• Analyze the economic value and environmental impact of process concepts.
• Lead technology transfer: draft transfer documents, run process fit assessments, risk analyses and process documentation.
• Represent the organization in multi-functional teams to align deliverables with the technology transfer timeline.
• Monitor manufacturing processes, lead problem resolution and provide troubleshooting guidance.
• Apply design of experiments and statistical analysis to identify process improvements.
• Author, review and approve process documentation for validation and commercialization, and contribute to NDAs, process performance qualification and continued process verification.
• Provide on-the-floor support for scale-up and act as subject matter expert for process risk analysis.

Required profile

• Basic qualifications: doctorate; or master's degree with 2 years of engineering experience; or bachelor's degree with 4 years; or associate's degree with 8 years; or high school diploma/GED with 10 years of engineering experience.
• Preferred: experience with bioprocessing unit operations for ADCs and/or oligonucleotides, technology transfer and scale-up of synthetic molecules in a regulated environment, and authoring CMC Module 3, RTQs and annual reports.
• Strong communication and presentation skills.

Required skills

• First-principles modeling (reaction kinetics, mass transfer, separations, distillations, drying, hydrodynamics) across several platforms.
• Analytical techniques such as HPLC, GC, MS, NMR, FTIR, particle size determination.
• Data science and advanced statistical analysis.
• Knowledge of regulatory and cGMP requirements and command of lab and plant operations and safety practices.

What we offer

• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives and flexible work models where possible.