Sr Research Associate/Scientist, Bioanalysis
South San Francisco, CA
We are seeking a highly motivated individual with strong GLP bioanalysis experience. The successful candidate will work as a bench Sr Research Associate/ Scientist in the Pharmacology Department and participate in the method development, qualification, and sample analysis of drugs in biological matrices.
- Conduct bioanalytical method development and sample analysis using immunoassays to quantify protein therapeutics in biological matrices, assess drug immunogenicity.
- Manage sample logistics in support of preclinical and clinical studies
- Partner with CROs to manage and monitor outsourced PK/ADA assays
- Independently design, implement and analyze experiments, as well as follow and incorporate relevant published findings related to research, methodologies and technologies and propose scientifically based recommendations
- Troubleshoot assay performance and sample testing as needed
- Interpret and analyze data, contribute to bioanalytical reports, and communicate the findings to project teams
- Prepare and present technical information at internal/external meetings
- Keep accurate and up-to-date hard/electronic lab documents, and GLP training records
- Experience with method development and validation for PK and immunogenicity using immunoassay.
- Experience with LC-MS/MS for biotherapeutics is a plus
- Strong knowledge and extensive experience with GLP requirements and practices for a bioanalytical lab
- Ability to work independently and on teams with minimal supervision
- Demonstrated ability to troubleshoot bioanalytical methods
- Experience with outsourcing LBA, ADA, LC-MS/MS assays to CROs
- Strong analytical and critical thinking skills with the ability to interpret complex data
- Proficiency with Microsoft Office (Word, Excel, Power Point), Softmax and graphical computer programs (e.g. SIGMAPLOT)
- Excellent communication skills
- Detail oriented with good organizational, documentation and technical writing skills
- Sr Research Associate: BS/MS in analytical chemistry or related disciplines, with more than 5 years of bioanalytical industry experience.
- Associate Scientist: BS/MS in analytical chemistry or related disciplines, with more than 10 years of bioanalytical industry experience.
- Scientist: 1+ years industry experience with PhD in biology, analytical chemistry or related disciplines
- Excellent team-player comfortable in fast-moving, dynamic environment
- Energetic, resourceful self-starter with high integrity
- Innovative, enthusiastic, creative, and accountability
- Adaptable and resilient with a problem-solving orientation