Senior LC-MS/MS Scientist — Bioanalytical PK Expert

Yowei Therapeutics; Milpitas (CA); On-site; USD 130,000 - 200,000; Full time

Benefits offered by this job

Medical insurance (Kaiser/Blue Shield)

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k with match

Paid time off (PTO) 10 days

Paid holidays

Carpool/commute support

Cell phone reimbursement

Employee rewards program

Company events

Team building events

Job summary

Yowei Therapeutics seeks a Senior Scientist to own LC-MS/MS for regulated bioanalytical testing in support of pharmacokinetic (PK) studies for peptide clinical programs. This hands-on, single-owner role covers method development and validation end-to-end.

The candidate will author validation protocols/reports, address analytical challenges, and interact with CMC, QA, and clinical teams to ensure submission-ready documentation.

Qualifications

• Hands-on LC-MS/MS bioanalysis development/validation
• Experience with regulatory validation under ICH M10 or FDA guidance
• Authoring validation protocols, reports, and regulatory submissions

Responsibilities

• Develop, qualify, and validate LC-MS/MS methods for peptide analytes in biological matrices (plasma/serum/tissue) to support PK studies.
• Execute full bioanalytical method validation per ICH M10 guidelines.
• Design study analysis runs, QC schemes, and reanalysis criteria; manage ISR and run acceptance.
• Address peptide-specific challenges and ensure data integrity across analyses.
• Collaborate with CMC, QA, and clinical teams; lead MS ownership for projects.

Skills

LC-MS/MS

Bioanalysis

GLP

ICH M10

Data integrity

Independent work

Education

PhD in analytical chemistry/biochemistry

MS/BS with 8–12 years GLP/GMP

Job description

Yowei Therapeutics seeks a Senior Scientist to own LC-MS/MS for regulated bioanalytical testing in support of pharmacokinetic (PK) studies for peptide clinical programs. This hands-on, single-owner role covers method development and validation end-to-end.

The candidate will author validation protocols/reports, address analytical challenges, and interact with CMC, QA, and clinical teams to ensure submission-ready documentation.