Process Development Associate Scientist - Cellular Sciences / Biosafety Development

About the position

The Process Development Associate Scientist in Cellular Sciences / Biosafety Development at Amgen plays a crucial role in ensuring patient safety through the performance of molecular assays and viral clearance assessment studies for pharmaceutical products. This position focuses on model virus production and conducting GMP Viral Clearance studies to support regulatory filings with the FDA. The role involves technology development for detecting adventitious agents and requires collaboration within a dedicated team.

Responsibilities

• Perform molecular assays and viral clearance assessment studies for pharmaceutical products.
• Support model virus production via characterized cell lines.
• Conduct GMP Viral Clearance studies to support IND and MA filings to the FDA.
• Utilize molecular assays for the detection of adventitious agents, including mycoplasma, bacteria, or fungus.
• Apply chromatography techniques for the purification or removal of viruses.
• Develop and qualify molecular assay methods.
• Train other employees in relevant techniques and procedures.
• Manage materials and supply inventory.

Requirements

• Bachelor's degree and 3 years of scientific experience or Master's degree and 1 year of scientific experience.
• Hands-on experience with maintenance of cell culture lines.
• Experience with molecular biology techniques including qPCR; method development experience is a plus.
• Experience with purification systems, including AKTA Chromatography system.
• Strong written and verbal communication skills.
• Ability to work as a member of a small team and follow/develop methods.
• Good planning and project execution skills.
• Ability to interpret and present data clearly and concisely.
• Understanding of cell biology, virology, and mathematical principles.

Nice-to-haves

• Experience with method development in molecular biology.
• Familiarity with GMP practices and regulations.

Benefits

• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Vision insurance
• Retirement plan