Scientist - QC

Siegfried•Irvine, CA

About The Position

Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: The Scientist serves as a senior technical expert within the QC Chemistry laboratory, providing advanced scientific leadership while remaining actively engaged in routine and non-routine QC testing activities. This position combines expert-level chromatographic capability with hands-on release and stability testing responsibilities. The Scientist functions as the technical authority for complex analytical methods, supports inspection readiness, and ensures robust lifecycle management of analytical procedures supporting sterile drug product manufacturing. All activities are performed in compliance with cGMP, GDP, and applicable regulatory requirements.

Requirements

Knowledge of quality systems, FDA, ICH and compendial requirements.
Advanced expertise in LC/GC analyses within a GMP QC laboratory.
Strong experience executing and defending method validations and transfers.
Demonstrated leadership in analytical investigations and root cause analysis.
Ability to independently assess data integrity and product quality impact.
Proficient in Microsoft Excel and Word, Empower, Chromeleon, TrackWise, CDS Systems and LabWare 8 for data analysis, chromatographic processing, quality management, and laboratory information management.
Strong written and oral communication skills.
Capable of using good reason and judgment to make and defend recommendations affecting product disposition.
Positive team player in a fast-paced, regulatory environment.
Ph.D. in Analytical Chemistry preferred
5-10+ years of experience in cGMP laboratory environment

Nice To Haves

Experience in sterile drug product or ophthalmic manufacturing
Demonstrated experience supporting regulatory inspections

Responsibilities

Independently execute complex QC chemistry testing supporting raw material, in-process and finished product release, stability studies and cleaning validation programs.
Serve as technical lead for advanced chromatographic analyses (HPLC/GC), including assay, impurities, stability-indicating methods and method troubleshooting.
Lead and perform high-risk or technically complex testing impacting product disposition decisions.
Assist in the performance of internal and external audits.
Act as lead investigator for significant OOS, OOT and deviation investigations involving analytical root cause.
Provide expert guidance in method validation, transfer, verification, and lifecycle management of analytical methods used in QC.
Author and review validation protocols, technical reports and investigation documentation.
Support routine QC review and approval of chromatographic data within CDS systems.
Troubleshoot instrumentation performance issues and coordinate vendor service as needed.
Represent QC during regulatory inspections and customer audits as analytical subject matter expert.
Provide mentorship and technical training to Chemists and Associate Chemists.
Proactively identify optimization opportunities within analytical procedures and laboratory processes to improve robustness and compliance.
Utilize Labware 8 LIMS and chromatography data systems (Empower, Chromeleon or equivalent) for review and oversight activities.
Follow cGMP requirements, safety standards and applicable standard operating procedures.
Performs additional responsibilities as assigned by the immediate supervisor or manager to support departmental and organizational objectives.