Lead LC-MS Characterization Scientist, Biologics

Roche; South San Francisco (CA); On-site; USD 121,000 - 224,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech seeks a lead scientist to head MS characterization across biologic development, from early stages through launch. You will design, execute, and interpret LC-MS analyses to gain deep structural understanding of protein modalities and resolve technical root causes.

Develop phase-appropriate MS methods and MAM strategies to quantify CQAs and PTMs, ensuring analytical control. You will collaborate with cross-functional teams, mentor staff, and author filing-ready MS sections for regulatory

Qualifications

• Lead the mass spectrometry (MS) characterization efforts across biologic development.
• Strong collaboration and communication with multidisciplinary teams.

Responsibilities

• Lead MS strategy and execution from early development to commercial launch.
• Design, execute, and interpret LC-MS analyses to understand protein modalities and resolve root causes.
• Develop phase-appropriate MS methods and multi-attribute method (MAM) strategies.
• Identify and quantify CQAs and PTMs to ensure analytical control.
• Support process development milestones including cell line selection, purification, formulation, stability, and variant characterization.
• Prepare and file MS characterization sections for IND/BLA/MAA submissions and participate in regulatory interactions.
• Mentor team members in MS data interpretation and promote modern analytical capabilities.

Job description

Genentech seeks a lead scientist to head MS characterization across biologic development, from early stages through launch. You will design, execute, and interpret LC-MS analyses to gain deep structural understanding of protein modalities and resolve technical root causes.

Develop phase-appropriate MS methods and MAM strategies to quantify CQAs and PTMs, ensuring analytical control. You will collaborate with cross-functional teams, mentor staff, and author filing-ready MS sections for regulatory