Protein Mass Spec Analyst – Process Development Senior Scientist
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Job Detail
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Job Description
What you will do
Let’s do this! Let’s change the world!
Amgen is currently seeking a Sr. Scientist – Mass Spec Chemist in our Pre-Pivotal Development team in Rockville, MD. This group is responsible for early phase analytical development, including method development, method qualification, method transfer, process and product development support. The individual will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for early phase protein therapeutic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings.
- Work in a cross-functional team environment to advance therapies in early-stage development.
- Analyze early-stage protein-based therapies with advanced techniques such as liquid chromatography, mass spectrometry, capillary electrophoresis, as well as other methods.
- Troubleshoot and maintain laboratory equipment.
- Analytical method development, qualification, transfer to GMP group.
- Support process development including upstream (cell line, cell bank, cell culture development), downstream (impurities analysis, in process testing), formulation group (formulation screening, compatibility) and protein characterizations. Support research group’s molecules generations, validation, and potential new molecule nomination for clinical study.
- Implement and optimize automation and AI-driven methodologies to enhance efficiency and accuracy in therapeutic development processes.
- Leverage machine learning algorithms and robotics for high-throughput testing and data analysis.
- Other duties include data analysis, preparation of electronic notebook records of experimental data, authorship of technical protocols and reports, presentation of results at team meeting, and support for regulatory filings as needed.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
- Bachelor’s degree and 5 years of Scientific experience OR
- Master’s degree and 3 years of Scientific experience OR
- Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
Preferred Qualifications:
- Excellent laboratory skills with 3+ years of experience in protein characterization including LC-MS, HIC, SEC, IEX, RP, HILIC, CE-SDS, cIEF etc.
- Strong understanding of protein analysis, structure elucidation and characterization.
- Expertise handling, troubleshooting, and maintaining CE and LC/MS instruments
- Expertise using CE and LC/MS operation and data analysis software.
- Experience in implementing automation solutions within laboratory settings.
- Proficiency in leveraging AI technologies for data analysis and process optimization.
- Works well in cross-functional teams, and across various geographic locations in different time zones.
- Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.
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Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile.