A biopharma company in the Bay Area is actively seeking a new Scientist to join their growing Technical Development Department. In this role, the Scientist will be responsible for developing physicochemical analytical methods (HPLC, CE, LC/MS), performing extensive characterization on both early and late-stage molecules for orphan diseases, and supporting 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
- Author and review protocols, technical reports, and method SOP
- 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, regulatory affairs, etc.
- Maintain lab safety, equipment, and reagents
Qualifications:
- Previous experience as a Scientist (2+ years of experience with a Ph.D; or , 4+ years of experience with a Master’s Degree; or , 6+ years of experience with a Bachelor’s Degree)
- 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
- 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
