A pharmaceutical company in California is currently seeking a new Scientist to join their growing CMC Analytical Development team in San Francisco. In this role, the Scientist will be responsible for developing physiochemical analytical methods (HPLC, CE, LC/MS), perform extensive characterization on both early and late-stage molecules for orphan diseases, and support process and formulation development through routine testing.
Responsibilities:
- Develop analytical methods, support extended characterization studies for biologics-based therapeutics
- Support process and formulation development by providing analytical testing results
- Work closely with team members in analytical development and quality control, as well as other functions such as Manufacturing, CMC team, Project Development and Regulatory, to ensure the timely development, validation, testing and release of materials to be used to support clinical activities
- Author and review protocols, technical reports, and method SOPs
- Contribute to laboratory and manufacturing investigations, develop and execute experiments in the laboratory as needed
- Collaborate effectively with other functions, including process development, manufacturing, quality control, quality assurance, manufacturing, regulatory affairs etc.
- Maintain lab safety, lab equipment and reagents
- Perform other duties, as needed
Qualifications:
- PhD & 2+ years of experience; or, Master's Degree & 4+ years of experience; or, Bachelor's Degree & 6+ years of relevant industry experience
- Experience with HPLC/UPLC's, CE and iCIEF analytical methods and instrumentation
- Experience of state-of-the-art analytical technologies for biologics, such as HPLC (various modes and detections), CE-SDS, icIEF, LC-MS, peptide map, glycan map, disulfide map, DSC, FT-IR, CD, fluorescence spectroscopy, particle analysis
- Self-motivated with high attention to details, ability to analyze, summarize and present data and significant conclusions to key stakeholders and decision maker
- Excellent written and verbal communication skills
- Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
- Ability to engage collaboratively with CMC functions and external testing laboratories