Senior QC Scientist – Biopharma Analytics & Compliance

MilliporeSigma; Carlsbad (CA); On-site; USD 68,000 - 99,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma in Carlsbad, CA is seeking a QC Senior Scientist I to support daily Quality Control operations, performing a wide range of analytical tests from raw materials to final product under cGMP guidelines.

You will collaborate with internal and external teams, aid method transfers and stability programs, and mentor junior analysts while maintaining a safe, compliant laboratory environment.

Qualifications

• Bachelor’s Degree in Biology, Chemistry or related Life Science discipline.
• 6-10 years of experience in the biopharmaceutical industry.
• OR
• Master’s Degree in Biology, Chemistry or related Life Science discipline
• 5+ years of experience in the biopharmaceutical industry.
• OR
• PhD in Biology, Chemistry or related Life Science discipline
• 3+ years of experience in the biopharmaceutical industry.

Responsibilities

• Perform a wide variety of analytical testing methods including raw material, in-process, and final product testing.
• Support lab readiness for testing and client audits.
• Assist SOP generation, protocol generation, data summarization, and reporting.
• Support change controls, CAPAs, investigations, and related documentation.
• Support method onboarding, transfers, qualifications, and validations.
• Support stability programs, including scheduling and timelines.
• Coordinate raw material qualification activities for commercial clients and reporting.
• Communicate with internal/external network partners and Product Teams.
• Promote a safety-first culture.
• Act as a resource for junior analysts.

Skills

Analytical testing

Data analysis

GMP documentation

Regulatory audits support

Education

Bachelor’s Degree in Biology, Chemistry or related Life Science discipline

Master’s Degree in Biology, Chemistry or related Life Science discipline

PhD in Biology, Chemistry or related Life Science discipline

Tools

ELISA

HPLC/UPLC

qPCR/ddPCR

Spectroscopy

Cell culture

CE-SDS

Job description

MilliporeSigma in Carlsbad, CA is seeking a QC Senior Scientist I to support daily Quality Control operations, performing a wide range of analytical tests from raw materials to final product under cGMP guidelines.

You will collaborate with internal and external teams, aid method transfers and stability programs, and mentor junior analysts while maintaining a safe, compliant laboratory environment.