Senior Scientist

Merck•Carlsbad, CA

6d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.