Lead Analytical Scientist: Method Validation & cGMP

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

Benefits offered by this job

Health insurance

Paid time off

Retirement plan

Bonus potential

Job summary

MilliporeSigma in Carlsbad, CA is seeking an Analytical Scientist to lead validation and transfer of analytical methods for GMP viral vector programs. You will conduct advanced testing (qPCR, ddPCR, HPLC, CE-SDS, ELISA, flow cytometry) and ensure data integrity, compliance, and inspection readiness while mentoring teams.

The role requires a Bachelor’s in life sciences and 4+ years leadership experience, with strong knowledge of cGMP, ICH guidelines, and biologics analytics.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 4+ years leadership experience in analytical sciences.
• Strong knowledge of cGMP, ICH guidelines, and QA/QC systems.

Responsibilities

• Perform advanced cGMP analytical testing using qPCR, ddPCR, HPLC, CE-SDS, ELISA, and Flow Cytometry.
• Lead method qualification, validation, and transfer activities across sites.
• Author and review SOPs, validation reports, and transfer documentation.
• Design and execute analytical studies, trend data, and present recommendations.
• Investigate Invalid, OOS and OOT results with root-cause analysis.

Skills

Leadership experience

Analytical testing

Mentoring

cGMP knowledge

Regulatory compliance

Data analysis

Education

Bachelor’s degree in life sciences

Tools

qPCR

ddPCR

HPLC

CE-SDS

ELISA

Flow Cytometry

Job description

MilliporeSigma in Carlsbad, CA is seeking an Analytical Scientist to lead validation and transfer of analytical methods for GMP viral vector programs. You will conduct advanced testing (qPCR, ddPCR, HPLC, CE-SDS, ELISA, flow cytometry) and ensure data integrity, compliance, and inspection readiness while mentoring teams.

The role requires a Bachelor’s in life sciences and 4+ years leadership experience, with strong knowledge of cGMP, ICH guidelines, and biologics analytics.