Process Development Scientist - Analytical Biologics

Amgen - Cambridge, MA

Full-time - Entry Level

Hybrid - Cambridge, MA

Chemical Manufacturing

About the position

The Process Development Scientist - Analytical Biologics at Amgen is responsible for supporting the development and qualification of analytical methods for protein-based biologic therapies. This role involves working in a cross-functional team to analyze late-stage therapies using advanced techniques, developing novel processes, and managing project workflows. The position emphasizes collaboration, technical expertise, and the ability to troubleshoot and maintain laboratory equipment, all while contributing to the mission of serving patients.

Responsibilities

• Support the development and qualification of analytical methods for protein-based biologic therapies.
• Analyze late-stage protein-based therapies using techniques such as capillary electrophoresis, liquid chromatography, and mass spectrometry.
• Develop, qualify, and transfer analytical methods in collaboration with subject matter experts and quality control scientists.
• Develop novel processes or approaches to solve problems within analytical sciences.
• Manage project work packages or workflows independently.
• Integrate results within work groups and cross-functional teams into experimental design.
• Conduct data analysis and prepare electronic notebook records of experimental data.
• Author technical protocols and reports, and present results at team meetings.
• Support regulatory filings as needed.
• Troubleshoot and maintain laboratory equipment.
• Provide technical support and troubleshooting for analytical issues.
• Collaborate with cross-functional teams to support product development and innovation.

Requirements

• Bachelor's degree and 4 years of scientific/pharmaceutical experience; OR Master's degree and 2 years of scientific/pharmaceutical experience; OR Doctorate degree.
• Degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline.
• Excellent laboratory skills with 3+ years of experience in industry laboratories supporting analysis and characterization of protein therapies.
• Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE-SDS, cIEF/icIEF, HIC, SEC, IEX, RP, HILIC, MS, etc.
• Expertise handling, troubleshooting, and maintaining CE and LC instruments.
• Expertise using CE and LC operation and data analysis software.
• Experience with data processing and statistical analysis software tools.
• Ability to independently prioritize, schedule, and manage multiple tasks to meet deliverables.
• Proven ability to lead small projects and/or work packages.
• Ability to work in a matrix team environment and collaborate effectively.
• Excellent written and oral communication skills.

Nice-to-haves

• Experience with advanced analytical techniques and methodologies in a laboratory setting.
• Familiarity with regulatory requirements for biologics development.

Benefits

• Comprehensive employee benefits package including health, dental, and vision coverage.
• Retirement and Savings Plan with generous company contributions.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.