Scientist 2

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. 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.

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.

Minimum Qualifications

• 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