Senior/Principal Scientist- Mass Spectrometry

Roche • South San Francisco, CA

21h

About The Position

The BioAnalytical Sciences (BAS) Department - Assay Development & Technology at Genentech, a world-class bioanalytical center of excellence, is seeking a highly motivated and creative Senior or Principal Scientist to join the Mass Spectrometry Team. You will join an innovative and collaborative environment focused on the development, evaluation, and implementation of state-of-the-art quantitative bioanalytical methods to support biopharmaceuticals across the product pipeline. You will evaluate, develop, and implement cutting-edge proteomics and immuno-enrichment mass spectrometry (MS)-based methods. You will deliver high-quality bioanalytical methods and data in compliance with global regulatory and industry standards. Additionally, you will collaborate cross-functionally to support the development of transformative therapies for patients. The Opportunity Operating in a fast-paced environment: This role spans the development lifecycle from early development through clinical studies. Assay Development: You will develop, characterize, qualify, and transfer LC-MS-based assays across various biological matrices, tissues, and species to quantify biotherapeutic levels and biomarkers. Strategic Leadership: You will formulate bioanalytical strategies, manage project timelines, present technical data to scientific review committees, and lead bioanalytical working groups. You will also represent BAS on project and cross-functional teams. External Oversight: Provide subject matter expertise for the technical transfer of assays to Contract Research Organizations (CROs) for validation. Provide technical oversight, troubleshooting, and documentation review as necessary for preclinical and clinical studies. Regulatory Contributions: Author bioanalytical and immunogenicity sections for regulatory filings (e.g., IND, BLA) and responses to health authority inquiries. Innovation: You will proactively assess and implement emerging LC-MS bioanalytical technologies to enhance departmental capabilities. Who You Are: You have a PhD or equivalent in Analytical Chemistry, Biochemistry, Immunology, or a related discipline is required. Candidates without a formal PhD who possess comparable depth of training and meet job-specific criteria will be considered.

Requirements

• PhD or equivalent in Analytical Chemistry, Biochemistry, Immunology, or a related discipline is required. Candidates without a formal PhD who possess comparable depth of training and meet job-specific criteria will be considered.
• In-depth, hands-on experience using LC-MS to identify, characterize, and develop quantitative assays for protein therapeutics and biomarkers in complex biological matrices is necessary.
• A proven track record of peer-reviewed publications in protein mass spectrometry, demonstrating the ability to work independently or in teams and to solve complex bioanalytical challenges, is essential.
• Demonstrated ability to think strategically, anticipate and identify key issues, and facilitate problem-solving and resolution.
• Excellent written and verbal communication, interpersonal, and organizational skills are required.
• Proficiency with standard scientific text, graphic, and presentation software is required.

Nice To Haves

• Experience with nano-, micro-, and analytical-flow LC systems is highly desirable.
• Experience with HRMS (Orbitrap Lumos/Astral/Exploris, TOF), QQQ (6500 and 7500), and ion mobility (FAIMS and SelexION) platforms is preferred.
• Expertise in immunoaffinity capture and tissue analysis is highly beneficial.
• Proficiency in LC-MS-based peptide/protein biotransformation and stability analysis is preferred.
• Experience with LC-MS-based nucleic acid therapeutic (e.g., RNA, oligonucleotides) assay development is highly desirable.
• Fluency with proteomics mass spectrometry data processing software such as Protein Metrics, BioPharma View, BioPharma Finder, PEAKS, and Proteome Discoverer is highly preferred.
• Experience with automation systems (KingFisher, AssayMAP) is advantageous.
• Experience with database and data archival systems is preferred.
• Familiarity and experience with programming (Python, R, C#) to analyze large datasets is a plus.

Responsibilities

• Evaluate, develop, and implement cutting-edge proteomics and immuno-enrichment mass spectrometry (MS)-based methods.
• Deliver high-quality bioanalytical methods and data in compliance with global regulatory and industry standards.
• Develop, characterize, qualify, and transfer LC-MS-based assays across various biological matrices, tissues, and species to quantify biotherapeutic levels and biomarkers.
• Formulate bioanalytical strategies, manage project timelines, present technical data to scientific review committees, and lead bioanalytical working groups.
• Provide subject matter expertise for the technical transfer of assays to Contract Research Organizations (CROs) for validation.
• Provide technical oversight, troubleshooting, and documentation review as necessary for preclinical and clinical studies.
• Author bioanalytical and immunogenicity sections for regulatory filings (e.g., IND, BLA) and responses to health authority inquiries.
• Proactively assess and implement emerging LC-MS bioanalytical technologies to enhance departmental capabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees