Position Overview:
Scientist (Analytical Development and Quality Control) conducting analytical method development and material characterization to support drug substance/drug product development; providing operational oversight at external CDMO/CTL partners; managing reference standards and impurity markers; collaborating in CMC risk management; authoring technical reports. Onsite in Brisbane, CA.
Key Responsibilities:
- Characterize and develop analytical methods internally, including 2D-LC for impurity profiling and method derisking/adaptation to MS
- Structural elucidation using high-resolution Orbitrap Tribrid mass spectrometry
- QbD HPLC method development using multivariate DOE software
- Perform forced degradation and elucidate degradation mechanisms
- Conduct predictive stability studies and model packaging configurations/long-term stability
- Author analytical development reports, stability reports, and storage statements
- Manage documentation/data; support protocol development and method transfer troubleshooting
- Liaise with Medicinal Chemistry, Bioanalytical, DMPK, and Preclinical; comply with cGMP/internal SOPs
- Manage reference standards/impurity markers; travel up to 5%
Required Qualifications:
- Advanced degree (Chemistry/Pharmaceutics or related): BS 10+ yrs, MS 6+ yrs, or PhD up to 4 yrs
- Expertise operating/maintaining mass spectrometers
- Experience operating HPLC and developing methods
- Ability to interpret data and communicate in cross-functional teams
- Ability to meet project timelines; strong collaboration skills
Bonus Qualifications:
- Accurate mass instrumentation (e.g., Orbitrap Tribrid), 2D-LC operation
- Structure determination of small molecule impurities/metabolites
- Protein/ADC characterization by MS; familiarity with other characterization techniques
- Reference standard management, stability programs, method validation
- Familiarity with ICH guidelines, cGMPs, pharmacopeial chapters
Application Process:
- Submit an application (US work authorization required).