About the Company
Amgen is a global biotechnology company, one of the world’s largest independent biotechnology firms. Dedicated to unlocking the potential of biology for patients suffering from serious illnesses, Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. Our mission is to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. We are committed to an inclusive culture that values diverse talent and fosters an environment where people can do their best work.
Job Description
We are seeking a highly motivated and skilled Clinical Research Chemist to join our dynamic R&D team in Long Beach, CA. This role is critical for advancing our global pharmaceutical projects, focusing on the analytical development and testing of novel drug candidates. The ideal candidate will possess a strong background in analytical chemistry, method development, and validation within a regulated environment (GLP/GMP). You will contribute to preclinical and clinical phase studies by providing expert chemical analysis, characterization, and stability testing of investigational medicinal products. This is a high-demand position requiring meticulous attention to detail, a proactive approach to problem-solving, and the ability to collaborate effectively across multidisciplinary teams.
Key Responsibilities
- Develop, optimize, and validate analytical methods for drug substances and drug products in support of preclinical and clinical studies.
- Perform routine and non-routine chemical analysis using a variety of analytical techniques (e.g., HPLC, GC, Mass Spectrometry, FTIR, UV-Vis, dissolution).
- Conduct stability studies, analyze data, and interpret results according to ICH guidelines.
- Characterize impurities and degradation products to support formulation development and quality control.
- Write and review technical reports, protocols, and standard operating procedures (SOPs) in compliance with regulatory standards (GLP/GMP).
- Collaborate with drug discovery, process chemistry, pharmacology, and regulatory affairs teams.
- Maintain and troubleshoot laboratory equipment, ensuring proper calibration and functionality.
- Present scientific findings at internal meetings and contribute to scientific publications.
- Ensure strict adherence to safety regulations and quality assurance protocols.
Required Skills
- Expertise in a wide range of analytical techniques (HPLC, GC, MS, NMR, FTIR, UV-Vis).
- Strong understanding of method development, validation, and transfer.
- Proficiency in data analysis and interpretation, including statistical analysis.
- Knowledge of GLP, GMP, and ICH guidelines relevant to pharmaceutical development.
- Excellent problem-solving abilities and attention to detail.
- Strong written and verbal communication skills.
- Ability to work independently and as part of a team.
Preferred Qualifications
- PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
- Experience with large molecule analysis (biologics) and biosimilars.
- Familiarity with LIMS (Laboratory Information Management System) and electronic laboratory notebooks (ELN).
- Proven track record of scientific contributions (publications, presentations).
- Experience in a contract research organization (CRO) or pharmaceutical industry setting.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Paid time off (vacation, sick leave, holidays).
- Life insurance and disability benefits.
- Employee stock purchase plan.
- On-site fitness center and wellness programs.
- Professional development and tuition reimbursement.
- Relocation assistance (if applicable).
- Generous parental leave policy.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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