Scientist 2

The businesses of Merck KGaA, Darmstadt, Germany•Carlsbad, CA

1d•$77,600 - $116,400•Onsite

About The Position

MilliporeSigma is seeking a skilled and motivated Analytical Scientist to support a Viral Vector CDMO Facility in Carlsbad, California. The role focuses on validation of analytical methods and advanced analytical testing for all phases of GMP viral vector client programs, ensuring the accuracy and reliability of test results. The position contributes to the broader success of the company beyond its specific job duties. The scientist will provide analytical science leadership in cGMP biologics testing, method validation and transfer, and laboratory quality systems. Work spans assays including qPCR, ddPCR, HPLC, CE-SDS, ELISA, and flow cytometry. The role also involves translating complex data and investigations into evidence-based decisions, strengthening compliance and inspection readiness, and collaborating with and mentoring colleagues to support safety, quality, accountability, knowledge sharing, and continuous improvement. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

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-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 in an FDA-regulated environment, as well as 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.
Biologics or virology background; 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, 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 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 a culture of safety, quality, and knowledge sharing.