Scientist 2

Merck•Carlsbad, CA

18h

About The Position

MilliporeSigma is seeking a skilled and motivated analytical scientist to support a Viral Vector CDMO facility in Carlsbad, California. The role conducts advanced analytical testing and transfers and validates analytical methods for GMP viral vector client programs across all phases. It helps ensure accurate and reliable test results and contributes to company-wide needs beyond specific job duties. The scientist provides analytical leadership in cGMP biologics testing, method validation and transfer, and laboratory quality systems. Work spans assays such as qPCR, ddPCR, HPLC, CE-SDS, ELISA, and flow cytometry. The position interprets complex data and investigations to support evidence-based decisions, strengthens compliance and inspection readiness, and mentors and collaborates across teams to promote safety, quality, accountability, knowledge sharing, and continuous improvement.

Requirements

Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or another life sciences discipline.
4+ years of leadership experience.

Nice To Haves

Ability to drive strategic improvements and a track record of mentoring people at multiple levels.
Knowledge and technical expertise in biologics analytical techniques, method validation, and assay testing.
Academic or industry background in virology.
Strong critical and analytical thinking skills for problem-solving and improving outcomes.
Experience mentoring and leading junior associates.
Knowledge of cGMP manufacturing and quality systems in an FDA-regulated environment and ICH quality guidelines.
Proficiency in analytical techniques such as ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, and cell-based assays; method validation and transfer; data trending and statistics; and instrument maintenance.
Basic programming or data-analysis tools are a plus.
Knowledge of cGMP, ICH guidelines, and QA/QC systems; experience with regulatory submissions and deviations/CAPAs.
Excellent written and oral scientific communication, problem-solving, collaboration, adaptability, and mentoring ability.
Background in biologics or virology; experience with microbial testing, QA release testing, and GMP documentation.

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 and use root-cause analysis to identify corrective actions.
Maintain, troubleshoot, qualify, and verify laboratory instruments, and support calibration and preventive-maintenance programs.
Serve as a technical subject-matter expert during client discussions, audits, and inspections, ensuring compliance with cGMP, regulatory requirements, and ICH guidelines.
Train and mentor junior scientists, collaborate cross-functionally, drive continuous improvement, and promote safety, quality, and knowledge sharing.