Technical Development Principal Scientist, Mass Spectrometry Characterization Lead

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

The Opportunity

Lead the mass spectrometry (MS) characterization strategy and execution across all stages of biologic therapeutic development, from early development through to commercial launch.

Design, execute, and interpret complex liquid chromatography-mass spectrometry (LC-MS) analyses to establish deep structural understanding of protein modalities and resolve technical root causes.

Develop and implement phase-appropriate MS methods and advanced multi-attribute method (MAM) strategies where standard analytical assays fall short.

Identify, monitor, and quantify critical quality attributes (CQAs) and post-translational modifications (PTMs) to ensure reliable analytical control.

Support process development milestones, including cell line selection, purification, formulation, stability, minor variant characterization, and structure-function elucidation.

Author filing-ready MS characterization sections for global regulatory submissions (IND, BLA, and MAA) and represent technical packages in regulatory interactions.

Collaborate closely with multidisciplinary teams, analytical leads, and external research/manufacturing partners to achieve project delivery milestones.

Mentor scientific team members in MS data interpretation and champion modern analytical capabilities and best practices.

Who you are

You hold a Ph.D. with 4-6+ years of relevant experience, or an M.S./B.S. with 6-10+ years of experience in Analytical Chemistry, Biochemistry, Chemical Engineering, or a related field.

You bring deep analytical expertise in liquid chromatography-mass spectrometry (LC-MS) applied to the characterization of proteins or related therapeutic modalities.

You possess strong working knowledge of chemistry, manufacturing, and controls (CMC) drug development and regulatory filing processes (IND/BLA).

You demonstrate excellent collaborative, organizational, and communication skills, thriving both as an independent lead and as part of a dynamic, multidisciplinary team.

You are an agile problem-solver motivated by scientific curiosity, technical quality, and delivering meaningful results in a fast-paced environment.

Relocation benefits are available for this job posting.

Benefits

The expected salary range for this position based on the primary location of South San Francisco, CA is $120,800 - $224,300.

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below.

Genentech is an equal opportunity employer.

It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence.

The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases.

To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society.

Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.