Senior Analytical Scientist — GMP Validation & Viral Vector

MilliporeSigma; Carlsbad (CA); On-site; USD 78,000 - 117,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma in Carlsbad, CA seeks an Analytical Scientist to validate and transfer analytical methods supporting GMP Viral Vector programs. You will perform complex assays like qPCR, ddPCR, HPLC, and ELISA on cGMP materials and coordinate method development across sites.

You will author SOPs and reports, trend data, and investigate deviations while mentoring junior staff and ensuring regulatory readiness. Work in a collaborative, safety‑minded environment.

Qualifications

• Bachelor-level degree in chemistry, biochemistry or life science.
• 8+ years of GMP/ QC lab experience.
• Experience with method development, validation and tech transfers.

Responsibilities

• Perform complex analytical assays (qPCR, ddPCR, HPLC, CE-SDS, ELISA) on cGMP materials and meet project deadlines.
• Lead method development, qualifications, validations and tech transfers across sites.
• Author and review SOPs, protocols and reports per cGMP and ICH guidelines.
• Trend analytical data, document OOS/OOT results and perform root-cause investigations.
• Maintain, troubleshoot and qualify lab instrumentation with Facilities & Engineering support.
• Serve as SME for QC analytical methods during client interactions and regulatory inspections.
• Train and mentor junior scientists and promote safety and quality culture.
• Collaborate with QA, Manufacturing and clients to design studies and drive lab efficiency.

Skills

qPCR

ddPCR

HPLC

ELISA

CE-SDS

method development

validation

data trending

root-cause investigations

tech transfers

Education

Bachelor’s degree in Chemistry or Biochemistry

Master’s Degree in Chemistry or Biochemistry

Tools

qPCR systems

HPLC systems

ddPCR instruments

Job description

MilliporeSigma in Carlsbad, CA seeks an Analytical Scientist to validate and transfer analytical methods supporting GMP Viral Vector programs. You will perform complex assays like qPCR, ddPCR, HPLC, and ELISA on cGMP materials and coordinate method development across sites.

You will author SOPs and reports, trend data, and investigate deviations while mentoring junior staff and ensuring regulatory readiness. Work in a collaborative, safety‑minded environment.