Senior Scientist

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

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

MilliporeSigma is seeking a skilled and motivated Analytical Scientist with expertise in validation of analytical methods to support a Viral Vector CDMO Facility in Carlsbad, CA. The successful candidate will be responsible for conducting advanced analytical analyses, transferring and validating analytical methods to support all Phases of GMP Viral Vector client programs and ensuring the accuracy and reliability of test results. The Senior Scientist position, will have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

In this role, responsibilities include, but are not limited to:

• Perform complex analytical assays (qPCR, ddPCR, HPLC, CE-SDS, ELISA) on cGMP materials while ensuring strict data accuracy and meeting project deadlines.
• Lead, execute, and manage method development, optimization, qualifications, validations, and tech transfers across internal and external sites.
• Author, review, and approve technical documentation (SOPs, protocols, reports) in full alignment with cGMP, ICH guidelines, and regulatory standards.
• Trend analytical data, document OOS/OOT results, and apply critical thinking to execute root-cause investigations and corrective actions.
• Maintain, troubleshoot, and qualify laboratory instrumentation, partnering with Facilities & Engineering to manage calibration and preventive maintenance.
• Serve as the technical Subject Matter Expert (SME) for QC analytical methods during client interactions, regulatory inspections, and audits.
• Train, coach, and mentor junior scientists while actively promoting a culture of safety, continuous learning, and quality.
• Collaborate across teams (QA, Manufacturing, AD/PD, clients) to design studies, deliver actionable insights, and drive lab efficiency initiatives.

Physical Attributes

• Work in analytical testing lab.
• Bend, stoop, squat, crawl, kneel, climb, or reach overhead.
• Wear required PPE such as safety glasses, gloves, masks, and close-toed shoes.

Who You Are

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry or other life science discipline.
• 8+ years of experience in GMP environment or QC Laboratory.

Preferred Qualifications

• Master’s Degree in Chemistry, Biochemistry or other life science discipline.
• Experience with analytical techniques ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); method validation/transfer; data trending and statistics; instrument maintenance; basic programming or data analysis tools.
• Experience with cGMP, ICH guidelines, and QA/QC systems; experience with regulatory submissions and deviations/CAPAs.
• Experience with Biologics and Virology.
• Experience with QA release testing and GMP documentation.

Pay Range for this position: $77,900/yr - $116,900/yr

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

• Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

For more information click here.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!