Scientist Analytics

Bayer Healthcare LLC•Berkeley, CA

4h•Hybrid

About The Position

Scientist Analytics for Berkeley, CA to perform analytical testing, method development, validation & transfer in support of clinical product release, characterization and stability studies for therapeutic proteins and cell and gene therapies; maintain scientific records in compliance with regulatory requirements.

Requirements

Master’s in Molecular Biology, Cellular Biology, Molecular Genetics, Biotechnology, or closely related field
2 yrs experience handling and testing cell suspensions for injection in Grade B clean rooms
Performing cell culture, cell therapy & therapeutic protein analytical methods, including HPLC, capillary gel electrophoresis, imaged capillary isoelectric focusing, flow cytometry, digital droplet PCR, cell count and viability, endotoxin, and functional and potency assays
Using Empower CDS, Chromperfect, QX Manager and/or CytExpert software for data acquisition & analysis

Responsibilities

Perform analytical testing, method development, validation & transfer in support of clinical product release, characterization and stability studies for therapeutic proteins and cell and gene therapies.
Maintain scientific records in compliance with regulatory requirements.
Provide technical support for HPLC, capillary gel electrophoresis, imaged capillary isoelectric focusing, plate reader, flow cytometry, ddPCR, cell count and viability, and incucyte analytical systems.
Compile, enter & review data in cross-functional GMP regulated databases.
Write, review & revise standard operating procedures, protocols and reports for analytical methods, instruments, validation, and bridging studies.
Perform analytical method validation, method verification & transfer of characterization and release assays between groups, laboratories, and/or sites.
Operate, maintain, & troubleshoot analytical instrumentation, including tracking vendor qualifications, preventative maintenance, system suitability assessments, and routine in-house instrument maintenance.