Analytical Scientist II: Method Validation & cGMP Leadership

Millipore Corporation; Carlsbad (CA); On-site; USD 78,000 - 116,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

MilliporeSigma is seeking a skilled Analytical Scientist to support a Viral Vector CDMO Facility in Carlsbad, CA. You will lead validation, transfer and qualification of analytical methods across GMP programs, ensuring accuracy and regulatory compliance in cGMP biologics testing.

You will mentor junior scientists, collaborate cross-functionally, and serve as SME during client discussions, audits, and inspections, applying robust data analysis and problem-solving to drive continuous improvement.

Qualifications

• Bachelor's degree in Biology, Chemistry, Chemical Engineering, or related life sciences.
• 4+ years leadership experience.

Responsibilities

• Perform advanced cGMP analytical testing with qPCR, ddPCR, HPLC, CE-SDS, ELISA, and flow cytometry.
• Lead method qualification, validation, and transfer activities across internal and external sites.
• Author and review SOPs, work instructions, validation reports, and transfer documentation.
• Design and execute analytical studies, review data, and present actionable recommendations.
• Investigate Invalid, OOS and OOT results with root-cause analysis to identify corrective actions.
• Mentor junior scientists and ensure compliance with cGMP and ICH guidelines.

Skills

Analytical leadership

cGMP compliance

Data analysis

Mentoring

Cross-functional collaboration

Problem-solving

Education

Biology/Chemistry/Engineering or related Life Sciences

Tools

qPCR

ddPCR

HPLC/UPLC

CE-SDS

ELISA

Flow Cytometry

Job description

MilliporeSigma is seeking a skilled Analytical Scientist to support a Viral Vector CDMO Facility in Carlsbad, CA. You will lead validation, transfer and qualification of analytical methods across GMP programs, ensuring accuracy and regulatory compliance in cGMP biologics testing.

You will mentor junior scientists, collaborate cross-functionally, and serve as SME during client discussions, audits, and inspections, applying robust data analysis and problem-solving to drive continuous improvement.