About the Company
Amgen is one of the world’s leading biotechnology companies, committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. Our innovative medicines have changed the lives of millions of patients worldwide, and we are on track to serve millions more. Headquartered in Thousand Oaks, California, Amgen has a significant presence and impact across Southern California, including our state-of-the-art facilities that support critical research and development.
Job Description
We are seeking a highly motivated and experienced Senior Analytical Scientist with a strong focus on method development to join our dynamic team in Simi Valley, CA. This role is crucial in supporting the discovery, development, and commercialization of Amgen’s innovative drug products. The successful candidate will be responsible for developing, validating, and transferring robust analytical methods for drug substance and drug product characterization, release, and stability testing. This position requires a strong background in various analytical techniques, excellent problem-solving skills, and the ability to work collaboratively in a fast-paced environment.
Key Responsibilities
- Lead the development, optimization, and validation of analytical methods (e.g., HPLC, GC, Mass Spectrometry, CE, KF, dissolution) for small molecules and/or biologics.
- Design and execute experiments to troubleshoot complex analytical issues and improve method robustness.
- Author and review technical documents, including method development reports, validation protocols, and standard operating procedures (SOPs).
- Perform routine and non-routine analytical testing to support research, development, and quality control activities.
- Collaborate effectively with cross-functional teams including process development, formulation, quality assurance, and manufacturing.
- Mentor junior scientists and provide technical guidance on analytical strategies and best practices.
- Ensure compliance with cGMP/GLP regulations and company quality standards.
Required Skills
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 5+ years of relevant industry experience OR M.S. with 8+ years OR B.S. with 10+ years.
- Extensive hands-on experience in analytical method development, validation, and transfer for pharmaceutical or biotechnology products.
- Proficiency with a variety of analytical techniques, including HPLC/UPLC, GC, Mass Spectrometry (LC-MS, GC-MS), electrophoresis, and spectroscopy (UV/Vis, FTIR).
- Demonstrated expertise in chromatographic data acquisition and processing software (e.g., Empower, Chromeleon).
- Strong understanding of cGMP/GLP principles and regulatory requirements (FDA, ICH).
- Excellent problem-solving, data interpretation, and critical thinking skills.
- Effective written and verbal communication skills.
Preferred Qualifications
- Experience with biologics (e.g., monoclonal antibodies, proteins, peptides) characterization and method development.
- Familiarity with statistical tools for data analysis and method validation (e.g., JMP, Minitab).
- Experience in a leadership or mentorship role.
- Knowledge of QbD (Quality by Design) principles for analytical method development.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance plans.
- Generous paid time off (PTO) and company holidays.
- 401(k) retirement savings plan with company match.
- Employee stock purchase program.
- Life and disability insurance.
- On-site fitness centers and wellness programs.
- Tuition reimbursement and professional development opportunities.
- Employee assistance programs.
- Relocation assistance (if applicable).
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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