About the Role
Our client, a leading pharmaceutical research and development organization, is seeking an accomplished Senior Pharmaceutical Analytical Development Scientist for a fully remote position. In this critical role, you will lead the development, validation, and implementation of robust analytical methods for the characterization and quality control of drug substances and drug products. Your expertise will be essential in supporting early-stage development through to commercialization. As a remote-first employee, you will leverage your strong scientific acumen and communication skills to collaborate with diverse teams globally. The ideal candidate is a self-motivated individual with a proven track record in analytical chemistry within the pharmaceutical industry, capable of driving projects forward independently. This is a fantastic opportunity to contribute to life-changing therapies from your home office.
Key Responsibilities
- Develop and validate innovative analytical methods for the identification, quantification, and impurity profiling of drug substances and drug products using techniques such as HPLC, UPLC, GC, MS, and spectroscopy.
- Characterize physical and chemical properties of drug molecules and formulated products.
- Perform method transfer to Quality Control units and external partners.
- Troubleshoot analytical methods and instrumentation, resolving issues promptly.
- Execute stability studies and analyze the resulting data to determine shelf-life and storage conditions.
- Prepare comprehensive method development reports, validation protocols, and validation reports.
- Contribute to regulatory submissions by providing analytical data and documentation.
- Collaborate effectively with formulation development, process development, and regulatory affairs teams.
- Mentor junior scientists and contribute to the scientific advancement of the analytical development department.
- Stay updated on new analytical technologies, regulatory guidelines, and industry best practices.
Requirements
- Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or a closely related field.
- Minimum of 7 years of hands-on experience in analytical method development and validation within the pharmaceutical industry.
- Extensive expertise in chromatographic techniques (HPLC, UPLC, GC) and mass spectrometry (LC-MS, GC-MS).
- Proficiency in various spectroscopic techniques (UV-Vis, FT-IR, NMR).
- Thorough understanding of ICH guidelines and other relevant regulatory requirements for analytical development.
- Experience with dissolution testing and solid-state characterization techniques is highly desirable.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Excellent written and oral communication skills, with the ability to effectively present scientific findings.
- Proven ability to manage projects independently and work effectively in a remote, collaborative environment.
- Experience with software such as ChemStation, Empower, and various data analysis tools.
Benefits
- Our client offers a highly competitive salary, performance-based incentives, and stock options.
- This is a fully remote position offering maximum flexibility.
- We provide comprehensive health, dental, and vision insurance coverage.
- A generous annual leave allowance and paid sick leave contribute to work-life balance.
- Professional development opportunities, including access to scientific conferences and training programs, are readily available.
- A 401k plan with employer contribution is offered.
- Our client fosters a culture of scientific excellence, innovation, and employee well-being.