Job Description Summary: Amgen – Scientist, Analytical Development
This job description outlines a Scientist position within Analytical Development at Amgen, a biopharmaceutical company.The role focuses on providing analytical expertise too support biopharmaceutical process development and product lifecycle management.
here’s a breakdown of the key aspects:
Key Responsibilities:
* Analytical Deliverables: Providing and driving analytical data for biopharmaceutical processes and product development.
* Quality Control: Contributing to the control of product quality attributes and defining Quality Target Product Profiles.
* Method Development & Implementation: Developing, implementing, and commercializing analytical methods for various stages (in-process, release, stability).
* Regulatory Compliance: Ensuring analytical strategies meet regulatory expectations (US and worldwide).
* Data Analysis & Interpretation: Performing data analysis, statistical analysis, comparability studies, and managing method transfers.
* Troubleshooting & Inquiry: Applying troubleshooting methodologies to resolve analytical issues.
* Project Management: Managing analytical projects and resources.
* collaboration: Working effectively in a matrixed habitat with cross-functional teams.
* Technical Transfer: Managing the transfer of analytical methods to external contract organizations.
qualifications:
* Required:
* Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, etc.) and 2+ years of relevant experience in analytical development or operations.
* OR a Master’s degree in a scientific discipline and 0+ years of relevant experience in analytical development or operations.
* OR a Doctorate degree (PhD, PharmD, MD) in a scientific discipline or Operations.
* Preferred:
* 5+ years of experience as a Sr. Scientist in analytical development for biopharmaceuticals.
* Deep understanding of product quality attributes and regulatory requirements.
* Expertise in analytical techniques like HPLC,CE,LC/MS,ELISA.
* Experience with biopharmaceutical manufacturing processes.
* Experience in a matrix environment and technical transfer.
* Strong project management, organizational, and analytical skills.
What Amgen Offers:
* Competitive salary and Total Rewards Plan (health, financial, work/life balance, career development).
* Inclusive and diverse work environment.
* Opportunities for professional growth and contributing to impactful scientific advancements.
* Flexible work arrangements (potentially remote/hybrid).
In essence, this is a role for a skilled analytical scientist to contribute to the development and manufacturing of life-changing biopharmaceutical products.
