Lead MS Characterization Scientist – Biologics

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

Benefits offered by this job

Relocation benefits

Job summary

Genentech, Inc. is seeking a Technical Development Principal Scientist to lead mass spec characterization for biologic therapeutics from development through commercialization. You will bridge strategic leadership with hands-on MS expertise, guiding cross-functional teams to deliver high-impact analytical solutions.

The role requires a Ph.D. with extensive LC-MS experience and strong CMC/regulatory knowledge, with relocation benefits available for this posting in South San Francisco, CA.

Qualifications

• Ph.D. required with 4–6+ years of relevant experience; or MS/BS with 6–10+ years.
• Deep expertise in LC-MS applied to protein/therapeutic modality characterization.
• Strong knowledge of CMC drug development and regulatory filing processes (IND/BLA).

Responsibilities

• Lead MS characterization strategy across development stages, from early development to launch.
• Design and interpret LC-MS analyses to understand protein modalities and resolve root causes.
• Develop phase-appropriate MS methods and MAM strategies where needed.
• Identify CQAs and PTMs to ensure analytical control.
• Collaborate with cross-functional teams to meet project milestones.
• Mentor team members in MS data interpretation and best practices.
• Prepare filing-ready MS sections for regulatory submissions (IND/BLA/MAA).

Skills

LC-MS characterization

Analytical Chemistry

Biochemistry

Regulatory filings (IND/BLA)

Team leadership

CMC knowledge

Education

Ph.D. in Analytical Chemistry/Biochemistry/related field

M.S./B.S. in Analytical Chemistry/Biochemistry/related field

Job description

Genentech, Inc. is seeking a Technical Development Principal Scientist to lead mass spec characterization for biologic therapeutics from development through commercialization. You will bridge strategic leadership with hands-on MS expertise, guiding cross-functional teams to deliver high-impact analytical solutions.

The role requires a Ph.D. with extensive LC-MS experience and strong CMC/regulatory knowledge, with relocation benefits available for this posting in South San Francisco, CA.