Scientist 2

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

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Perquisites

Job summary

MilliporeSigma in Carlsbad, CA is seeking an Analytical Scientist to validate analytical methods for viral vector programs. The role requires leadership across cGMP biologics testing, method validation and transfer, and ensuring data integrity.

You will mentor teams, collaborate across functions, and maintain QA systems while supporting audits and regulatory expectations.

Qualifications

• Bachelor’s degree in biology, chemistry, chemical engineering or life sciences.
• 4+ years of leadership experience.
• Strong knowledge of cGMP and QA/QC systems.
• Experience with regulatory submissions and deviations/CAPAs.
• Excellent scientific communication and collaboration skills.

Responsibilities

• Perform advanced cGMP analytical testing using qPCR, ddPCR, HPLC, CE-SDS, ELISA, and Flow Cytometry.
• Lead method qualification, validation and transfer activities.
• Author and review SOPs, protocols, and validation reports.
• Design and execute analytical studies and interpret results.
• Investigate Invalid, OOS and OOT results and implement corrective actions.
• Train and mentor junior scientists and ensure inspection readiness.

Skills

cGMP expertise

Method validation

qPCR

ddPCR

HPLC

CE-SDS

ELISA

Flow cytometry

Mentoring

Education

Biology/Chemistry/Engineering

Tools

Instrument maintenance

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 conduct advanced analytical analyses, transfer and validate analytical methods to support all Phases of GMP Viral Vector client programs and ensures the accuracy and reliability of test results. The Quality Scientist position, like all positions at MilliporeSigma, will have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. You will be an analytical science leader specializing in cGMP biologics testing, method validation and transfer, and reliable laboratory quality systems across assays such as qPCR, ddPCR, HPLC, CE-SDS, ELISA, and flow cytometry. You turn complex data and investigations into clear, evidence-based decisions while strengthening compliance, documentation, and inspection readiness. You mentor and collaborate across teams to foster a culture of safety, quality, accountability, knowledge sharing, and continuous improvement.

Key Responsibilities

• Perform advanced cGMP analytical testing using qPCR, ddPCR, HPLC, CE-SDS, ELISA, and Flow Cytometry while ensuring data accuracy and quality.
• Lead method qualification, validation, and transfer activities across internal and external sites.
• Author, and review SOPs, work instructions, protocols, validation reports, and method-transfer documentation.
• Design and execute analytical studies, review and trend data, interpret results, and present actionable recommendations.
• Investigate Invalid, OOS and OOT results, applying root-cause analysis and critical thinking to identify corrective actions.
• Maintain, troubleshoot, qualify, and verify laboratory instruments while supporting calibration and preventive-maintenance programs.
• Serve as a technical SME during client discussions, audits, and inspections while ensuring compliance with cGMP, regulatory requirements, and ICH guidelines.
• Train and mentor junior scientists, collaborate cross-functionally, drive continuous improvement, and promote a culture of safety, quality, and knowledge sharing.

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

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

Preferred Qualifications

• Capability to drive strategic improvements, and track record of mentoring multiple levels.
• Knowledge and technical expertise with biologics analytical techniques, method validation, and assay testing.
• Academic or industry-based background in Virology.
• Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
• Experience mentoring and leading junior associates.
• Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
• Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); method validation/transfer; data trending and statistics; instrument maintenance; basic programming or data analysis tools a plus.
• Knowledge of cGMP, ICH guidelines, and QA/QC systems; experience with regulatory submissions and deviations/CAPAs.
• Excellent scientific communication (written and oral), problem-solving, collaboration, adaptability, and mentoring ability.
• Biologics/Virology background; experience with microbial testing, QA release testing, and GMP documentation

Pay Range for this position: $77,600-$116,400 per year.

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.

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RSREMD

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!