Principal Scientist

Merck•Carlsbad, CA

4h•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 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.

Requirements

Accomplished Analytical Scientist with 15+ years of experience, adept at leading method validation, transfer, and optimization programs in a cGMP/FDA-regulated environment.
Excel in performing advanced analytical testing (qPCR, ddPCR, HPLC, CE-SDS, ELISA) and in designing studies, analyzing complex data, and delivering actionable conclusions on schedule.
Strong technical leader who mentors junior scientists, authors and reviews protocols and reports, and drives cross-functional collaboration across QA, Manufacturing, and external partners.
Maintain rigorous data integrity, investigate OOS/OOT results with root-cause analysis, and implement corrective actions to improve quality and efficiency.
Bring a Biologics/Virology background or depth in microbial testing and QA release testing, coupled with excellent scientific communication and a continuous-improvement mindset.
Focus is on ensuring test accuracy, instrument reliability, and a culture of safety, quality, and knowledge sharing.
BS or MS in Chemistry, Analytical Science, or related field (or equivalent experience).
15+ years in GLP/GMP analytical environments; proven leadership in method validation/transfer; experience mentoring cross-functional teams.

Nice To Haves

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.

Responsibilities

Perform advanced analytical testing such as qPCR, ddPCR, HPLC, CE-SDS, and ELISA.
Lead and own large, cross-functional analytical programs (method development, validation/transfer, QC support) across multiple products or programs.
Define and drive the method validation/transfer strategy, including relevant considerations (e.g. ddPCR, qPCR, HPLC, ELISA, CE-SDS, FTIR, Gel Electrophoresis, etc.) with auditable documentation.
Mentor and develop scientists; provide technical leadership in data integrity, statistics, and interpretation of complex analytical data.
Lead root-cause investigations for OOS/OOT events; implement CAPAs with measurable effectiveness; drive continuous improvement.
Oversee instrument qualification (IQ/OQ/PQ/PM) and routine maintenance for critical platforms; ensure audit readiness.
Manage project planning, risk, and cross-site coordination; communicate status to leadership and clients/partners.
Develop and maintain SOPs, work instructions, and templates for compendial and non-compendial methods; ensure ALCOA+ data integrity.
Document and investigate out-of-specification (OOS) and out-of-trend (OOT) results, applying critical thinking to identify root causes and corrective actions
Train and mentor junior scientists, providing technical guidance and coaching.
Develop and review technical documentation (SOPs, work instructions, protocols, reports, transfer protocols).
Ensure compliance with cGMP, regulatory requirements, and ICH guidelines.
Drive continuous improvement initiatives to increase laboratory efficiency and analytical capability.
Collaborate cross-functionally with Quality Assurance, Manufacturing, Process and Analytical Development, Facilities & Engineering, global network and external partners and clients.
Promote a culture of safety, quality, learning, and knowledge sharing.