About the Company
Amgen is a leading global biotechnology company dedicated to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. With a presence in numerous countries, Amgen consistently pushes the boundaries of science to provide solutions for some of the world’s most challenging diseases. Our commitment extends beyond developing medicines; we strive to make a profound difference in patients’ lives through science-based innovations.
Job Description
We are seeking a highly motivated and experienced Clinical Research Chemist to join our dynamic R&D team in Burbank, CA. This is a critical role focused on supporting global pharmaceutical projects, working on high-demand initiatives that directly impact patient outcomes worldwide. The successful candidate will be instrumental in the analytical development, characterization, and quality control of novel therapeutic compounds, ensuring the highest standards of scientific rigor and regulatory compliance in a fast-paced environment. You will be a key contributor to the advancement of our diverse pipeline, collaborating with multidisciplinary teams across various stages of drug discovery and development.
Key Responsibilities
- Develop, optimize, and validate analytical methods (e.g., HPLC, LC-MS, GC, KF, dissolution) for drug substances and drug products.
- Conduct complex chemical analyses on samples from various stages of clinical development, including stability studies, formulation development, and manufacturing.
- Interpret and report analytical data, providing clear conclusions and recommendations to cross-functional teams.
- Manage and troubleshoot analytical instrumentation, ensuring proper calibration and maintenance.
- Contribute to the preparation of regulatory submissions (IND, NDA) by authoring relevant chemistry, manufacturing, and controls (CMC) sections.
- Collaborate with process chemists, formulators, and quality assurance specialists to resolve analytical issues and support project milestones.
- Stay current with industry trends, regulatory guidelines, and new analytical technologies.
- Ensure all laboratory activities comply with cGMP, ICH guidelines, and internal SOPs.
- Mentor junior scientists and contribute to a culture of scientific excellence and continuous improvement.
Required Skills
- PhD or Master's degree in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 4 years of experience in analytical development within the pharmaceutical or biotechnology industry.
- Proficiency in a wide range of analytical techniques, including HPLC, GC, LC-MS, UV/Vis, FTIR, and dissolution testing.
- Demonstrated experience in method development, validation, and transfer.
- Strong understanding of cGMP, ICH guidelines, and regulatory requirements for pharmaceutical products.
- Excellent problem-solving skills and attention to detail.
- Ability to work effectively in a team-oriented, fast-paced environment.
- Strong written and verbal communication skills.
- Experience with LIMS and other data management systems.
Preferred Qualifications
- Experience with advanced spectroscopic techniques (e.g., NMR, X-ray diffraction).
- Familiarity with statistical software for data analysis (e.g., JMP, Minitab).
- Prior experience working on global clinical trial projects.
- Leadership or mentoring experience.
- Publications in peer-reviewed journals or presentations at scientific conferences.
Perks & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off and holidays.
- Performance-based bonuses and stock options.
- Tuition reimbursement and professional development opportunities.
- On-site fitness center and wellness programs.
- Employee assistance program.
- Relocation assistance (if applicable).
- Company-sponsored events and community involvement initiatives.
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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