Senior Scientist, Peptide PK Bioanalysis (LC-MS/MS)

Yowei Therapeutics; Milpitas (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Disability insurance

401k

PTO 10 days

Holidays

Carpool/reimbursement

Rewards program

Company events

Team building

Job summary

Yowei Therapeutics is seeking a Senior Scientist to own LC-MS/MS bioanalytical testing for pharmacokinetic studies of peptide clinical programs. This hands-on role covers method development, validation, and regulatory documentation, with responsibility for the full lifecycle of analytical methods.

You will address peptide-specific challenges, collaborate across CMC, QA, and clinical teams, and operate as the sole MS owner in a GMP/GLP environment, ensuring readiness for submissions.

Qualifications

• Ph.D. in analytical chemistry, biochemistry, or related field with 4–7 years LC-MS/MS hands-on experience; or MS/BS with 8–12 years in GLP/GMP environments.
• Hands-on expertise in developing and validating LC-MS/MS bioanalytical methods for quantitation of peptides or biologics in biological matrices.
• Direct experience with regulated bioanalytical method validation and PK study analysis under ICH M10/GMP guidance.

Responsibilities

• Develop, qualify, and validate LC-MS/MS bioanalytical methods for quantitation of peptide therapeutics in plasma/serum/tissue to support PK studies.
• Execute full bioanalytical method validation per ICH M10; assess selectivity, calibration, accuracy, precision, and stability.
• Design study analysis runs, calibration/QC schemes, and ISR procedures; manage sample analysis with appropriate acceptance criteria.
• Establish fit-for-purpose peptide sample preparation and surrogate peptide strategies as needed.
• Address peptide-specific bioanalytical challenges and ensure data integrity for regulatory submissions.

Skills

LC-MS/MS method development

Bioanalytical testing

GLP/GMP compliance

ICH M10 familiarity

Validation protocols

Independent MS owner

Regulatory submissions

Education

PhD in analytical chemistry or biochemistry

4–7 years LC-MS/MS hands-on experience

MS/BS with 8–12 years GLP/GMP experience

Tools

LC-MS/MS

Job description

Yowei Therapeutics is seeking a Senior Scientist to own LC-MS/MS bioanalytical testing for pharmacokinetic studies of peptide clinical programs. This hands-on role covers method development, validation, and regulatory documentation, with responsibility for the full lifecycle of analytical methods.

You will address peptide-specific challenges, collaborate across CMC, QA, and clinical teams, and operate as the sole MS owner in a GMP/GLP environment, ensuring readiness for submissions.