Senior Scientist, Biologics Process Development

Biopharma Careers; Cambridge (MA); On-site; USD 126,000 - 171,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision coverage

Stock-based incentives

Flexible work options

Job summary

Amgen is seeking a Process Development Senior Scientist in the US to lead development, characterization, scale-up and support of drug substance processes for late-stage programs advancing from Ph II/III to commercialization. You will work in a cross-functional group with cell culture and purification scientists to deliver robust, scalable processes in a cGMP environment.

You will apply platform approaches, tackle drug substance challenges, and contribute to regulatory submissions, while

Qualifications

• PhD in Chemical Eng., Biochem., Biotech., Biomed., or related field.
• Experience in bioreactor process development or cell line development.
• Strong knowledge of current bioreactor technologies and data-driven development.

Responsibilities

• Develop, characterize, scale-up and support drug substance processes for commercial advancement.
• Collaborate with cell culture and purification scientists to advance pipeline.
• Deliver robust processes in a cGMP manufacturing environment.
• Prepare technical reports and support regulatory submissions as needed.

Skills

Leadership

Scientific communication

Cross-functional collaboration

Bioprocess understanding

Cell culture knowledge

Bioreactor development

Statistical analysis

DOE methods

Education

PhD in Life Sciences

Master’s degree + 2 years Life Sciences

Bachelor’s degree + 4 years Life Sciences

Tools

Bioreactor systems

Analytical instrumentation

DOE software

Job description

Amgen is seeking a Process Development Senior Scientist in the US to lead development, characterization, scale-up and support of drug substance processes for late-stage programs advancing from Ph II/III to commercialization. You will work in a cross-functional group with cell culture and purification scientists to deliver robust, scalable processes in a cGMP environment.

You will apply platform approaches, tackle drug substance challenges, and contribute to regulatory submissions, while