Principal Scientist- Bioanalytical Science, ADT

Genentech•South San Francisco, CA

51d

About The Position

We advance science so that we all have more time with the people we love. A Principal Scientist is a highly motivated and creative individual who develops, evaluates and implements state of the art bioanalytical methods to support biopharmaceuticals in the product development pipeline at Genentech. The Opportunity: As a member of the BAS team, you will be: Developing bioanalytical strategies to support protein therapeutics, will manage timelines and resources to meet project goals, and will present these strategies to various scientific review committees. Working with other Scientists, this individual develops, characterizes, and validates in vitro assay methods to quantify biotherapeutic levels in various species and biological matrices, to detect and characterize immune responses evoked by the biotherapeutic, to measure biomarkers, and for biological characterization in support of regulatory filings. Involved with manual laboratory work, the use of automation systems and various assay platforms, and participation in compliance and safety related activities. Contributing to departmental activities, and they may also be expected to help train colleagues. Responsibilities may also include supervision of one or more Research Associates. Writing sections of regulatory filings related to bioanalytical methods and characterization of biological activity. Involved with the assessment and implementation of state-of-the-art bioanalytical technologies and methods. Working in fast-paced cross-functional project team settings to help design and support pre-clinical and clinical studies, lead Bioanalytical Working Groups, and may be expected to lead pharmacology sub-teams or other cross-functional teams.

Requirements

Ph.D. in Biochemistry, Immunology, or a related field or an equivalent credential is required, with at least three years of experience including postdoctoral and/or industrial experience in bioanalytical aspects of biopharmaceutical development.
Background knowledge and practical experience in developing quantitative analyte, biomarkers, and anti-therapeutic antibody assays for protein therapeutics, along with a proven track record of publications solving complex bioanalytical problems are essential.
Familiarity with standard text, graphic, and presentation software is required, and familiarity with database/data archival software systems is helpful.
Excellent communication, interpersonal and organizational skills are required.

Nice To Haves

Pharmaceutical or biotechnology industry experience

Responsibilities

Developing bioanalytical strategies to support protein therapeutics
Managing timelines and resources to meet project goals
Presenting strategies to scientific review committees
Developing, characterizing, and validating in vitro assay methods to quantify biotherapeutic levels in various species and biological matrices
Detecting and characterizing immune responses evoked by the biotherapeutic
Measuring biomarkers
Biological characterization in support of regulatory filings
Manual laboratory work
Use of automation systems and various assay platforms
Participation in compliance and safety related activities
Contributing to departmental activities
Training colleagues
Supervision of one or more Research Associates
Writing sections of regulatory filings related to bioanalytical methods and characterization of biological activity
Assessment and implementation of state-of-the-art bioanalytical technologies and methods
Working in fast-paced cross-functional project team settings to help design and support pre-clinical and clinical studies
Leading Bioanalytical Working Groups
Leading pharmacology sub-teams or other cross-functional teams