Sr. RA/Assoc. Scientist - Bioanalytical

Location
Mountain View, CA
Posted
Jun 13, 2019
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Essential duties and responsibilities include the following: 

• Design, develop and execute PK and ADA assays in accordance with current industry standard for drug candidates in support of preclinical and clinical stage oncology programs.

• Analyze, summarize, interpret and present results in reports and tables, facilitating follow-up optimization experiments

• Author protocols, reports and SOPs in support of preclinical and clinical studies

• Effectively communicate with other departments within the organization as well as CROs.

• Provide project summaries/reports in project team meetings.

Basic Qualifications:

• BSc. / M.S. in relevant scientific discipline and at least 5+ years of bioanalytical laboratory experience a must.  Pharmaceutical, biotechnology or CRO experience highly desirable.

• Extensive knowledge of different PK and ADA formats (LBA, ELISA, MSD, Gyros, Quanterix Simoa etc.) and industry assay validation requirements a must

• Knowledge of other non-ELISA based formats such as Mass-spec, Capillary electrophoresis a plus

• Knowledge of SOP and GLP compliance, terminology and documentation 

• Knowledge of current FDA and EMA GLP/GCP compliance as it relates to bioanalytical PK and ADA methods

• Proven ability to think critically and creatively to identify and solve bioanalytical assay development challenges.

• Excellent written and verbal communication skills, and ability to write technical reports.

• Excellent organizational skills, attention to detail and the ability to work independently and within a multi-disciplinary environment as well as with external vendors

• Must thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.