Senior Bioprocess Development Scientist

Amgen Inc. (IR); Cambridge (MA); On-site; USD 126,000 - 171,000; Full time

Benefits offered by this job

Total Rewards Plan

Health, dental, vision coverage

Retirement plan with company match

Flexible work options

Job summary

Amgen Inc. in the United States seeks a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes for late-stage programs toward regulatory submission. You will collaborate with cell culture and purification scientists to advance biologics across multiple modalities.

Required: Ph.D. in a related field or a Master’s with strong bioprocess experience; demonstrated leadership and communication skills; experience with bioreactor

Qualifications

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing related field.
• Experience in bioreactor process development or cell line development.
• Knowledge of protein characteristics and critical attributes for bioprocess control.
• Familiarity with cGMP manufacturing and regulatory submissions (CMC).

Responsibilities

• Lead development, characterization, scale-up and support of drug substance processes for late-stage programs.
• Collaborate with analytical, drug product and cross-functional teams to deliver scalable manufacturing processes.
• Develop robust, compliant processes suitable for cGMP operation and regulatory submissions.
• Contribute to technology development and continuous improvement in bioprocesses.
• Document learnings and communications for senior stakeholders.

Skills

Bioreactor development

Cell culture development

DOE / Design of Experiments

Statistical analysis

Cross-functional collaboration

Leadership experience

Scientific communication

Education

Ph.D. in Chemical Engineering or related Bioprocess field

Master’s degree with Life Sciences experience

Job description

Amgen Inc. in the United States seeks a Process Development Senior Scientist to lead development, characterization, scale-up and support of drug substance processes for late-stage programs toward regulatory submission. You will collaborate with cell culture and purification scientists to advance biologics across multiple modalities.

Required: Ph.D. in a related field or a Master’s with strong bioprocess experience; demonstrated leadership and communication skills; experience with bioreactor