Principal Scientist- Bioanalytical Science, ADT

Genentech • South San Francisco, CA

120d • $141,500 - $262,900

About The Position

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. As a member of the BAS team, you will be: Developing bioanalytical strategies to support protein therapeutics, managing timelines and resources to meet project goals, and presenting 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.
• 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.
• Proven track record of publications solving complex bioanalytical problems.
• Familiarity with standard text, graphic, and presentation software.
• Familiarity with database/data archival software systems.
• Excellent communication, interpersonal and organizational skills.
• Pharmaceutical or biotechnology industry experience is a real advantage.

Responsibilities

• Developing bioanalytical strategies to support protein therapeutics.
• Managing timelines and resources to meet project goals.
• Presenting strategies to various scientific review committees.
• Developing, characterizing, and validating in vitro assay methods.
• Quantifying biotherapeutic levels in various species and biological matrices.
• Detecting and characterizing immune responses evoked by the biotherapeutic.
• Measuring biomarkers and biological characterization in support of regulatory filings.
• Involved with manual laboratory work and the use of automation systems.
• Participating in compliance and safety related activities.
• Contributing to departmental activities and training colleagues.
• Supervising one or more Research Associates.
• Writing sections of regulatory filings related to bioanalytical methods.
• Assessing and implementing state-of-the-art bioanalytical technologies and methods.
• Working in fast-paced cross-functional project team settings.
• Designing and supporting pre-clinical and clinical studies.
• Leading Bioanalytical Working Groups and pharmacology sub-teams.

Benefits

• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree