Remote Process Development Scientist - Scale-Up & Tech Transfer

Amgen; Cambridge (MA); On-site; USD 112,000 - 145,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Bonus eligibility

Job summary

Amgen is seeking a Process Development Scientist to support drug product commercialization and scale-up in a fast-paced environment. You will design and execute characterization studies, assess manufacturing impacts, and drive technology transfer across clinical and commercial facilities.

Collaboration with engineering, analytics, quality, and regulatory teams is essential to ensure lifecycle success. The role requires applying biochemical, biophysical, and statistical principles to

Qualifications

• Statistical evaluations of data for significance and correlations.
• Engineering/physics principles used for bench and pilot-scale models.
• Experience with process scale-up and technology transfer tools.
• Design and interpret process validation and sampling plans.
• Develop ongoing statistical monitoring and remediation plans.
• Prepare regulatory module 3 technical documents and responses.
• Laboratory skills: weighing, dispensing, aseptic handling, fill-finish work.

Responsibilities

• Provide technical input to commercialization teams and process development.
• Design, execute, document characterization studies and data packages.
• Evaluate product impact from manufacturing changes and raw materials.
• Lead technology transfers for pipeline and commercial products.
• Collaborate with cross-functional teams to ensure lifecycle success.
• Contribute to regulatory submissions enabling new processes.

Skills

Statistical data analysis

Process modeling

Process scale-up

Regulatory documentation

Statistical monitoring

Cross-functional collaboration

Bench and pilot scale work

Job description

Amgen is seeking a Process Development Scientist to support drug product commercialization and scale-up in a fast-paced environment. You will design and execute characterization studies, assess manufacturing impacts, and drive technology transfer across clinical and commercial facilities.

Collaboration with engineering, analytics, quality, and regulatory teams is essential to ensure lifecycle success. The role requires applying biochemical, biophysical, and statistical principles to