Senior Scientist Associate UHPLC

Location: Thousand Oaks CA

Onsite Flexibility: Onsite

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $30.00$33.00 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Perform GMP analytical testing in support of synthetic drug substance drug product raw material stability release and/or investigational activities. Independently execute established analytical methods accurately document laboratory activities evaluate and interpret analytical data and ensure testing is performed in accordance with approved procedures specifications and applicable GMP requirements. The individual is expected to work with minimal supervision exercise appropriate scientific judgment troubleshoot analytical and instrumentation issues and generate complete accurate reproducible and reliable data in accordance with data integrity expectations.

• Perform routine and non-routine GMP analytical testing of synthetic drug substance drug product raw materials stability samples and other materials as required.
• Execute testing according to approved analytical methods specifications SOPs protocols and applicable GMP requirements.
• Plan and organize laboratory activities to meet testing timelines and business priorities with minimal supervision.
• Accurately document sample preparation reagent and standard preparation instrument conditions calculations observations and results in accordance with GMP and data integrity requirements.
• Review analyze and interpret analytical data to ensure results are scientifically sound complete traceable and reliable.
• Operate and maintain standard laboratory equipment and analytical instrumentation.
• Experience with one or more analytical techniques such as HPLC/UPLC GC dissolution UV-Vis FTIR Karl Fischer ion chromatography wet chemistry and/or LC-MS is preferred.
• Troubleshoot analytical methods instrumentation sample preparation and laboratory execution issues and escalate when appropriate.
• Recognize atypical results laboratory events deviations and potential data-quality issues and promptly communicate them through appropriate GMP processes.
• Support laboratory investigations deviations CAPAs change controls method-related assessments and other quality-system activities as required.
• Support analytical method transfer qualification verification and validation activities.
• Effectively transfer analytical procedures into the GMP laboratory and identify scientifically justified modifications or improvements when appropriate.
• Prepare and review technical documentation including laboratory notebooks worksheets protocols reports summaries and other GMP documentation.
• Maintain appropriate control and traceability of standards reagents solutions samples and laboratory materials.
• Ensure laboratory activities comply with applicable safety requirements procedures and regulatory expectations.
• Communicate testing status analytical results technical issues and potential risks clearly to laboratory management and cross-functional stakeholders.
• Participate in scientific and technical discussions and provide interpretation of analytical data to the broader project team.
• Coordinate laboratory resources instrumentation materials and testing activities necessary to complete assigned work.
• Contribute to continuous improvement efforts focused on laboratory efficiency compliance data quality and operational excellence.
• Support regulatory inspections internal audits and laboratory readiness activities as needed.
• Train or provide technical guidance to other laboratory personnel when appropriate.
• Demonstrate sound judgment regarding when independent action is appropriate and when issues require escalation or additional scientific quality or management input.

• GXP background
• UHPLC experience
• Experience with at least one additional analytical technique (e.g. GC dissolution UV-Vis FTIR Karl Fischer ion chromatography wet chemistry and/or LC-MS)
• Working knowledge of GMP requirements good documentation practices and laboratory data integrity principles
• Demonstrated ability to independently execute analytical procedures and generate accurate reproducible and scientifically defensible results
• Experience troubleshooting analytical instrumentation and laboratory methods
• Ability to effectively organize multiple laboratory activities and meet established testing timelines
• Strong written and verbal communication skills with the ability to clearly document and communicate analytical results laboratory issues and scientific conclusions

• Experience performing analytical testing of synthetic pharmaceutical materials
• Experience with one or more analytical techniques such as HPLC/UPLC GC dissolution UV-Vis FTIR Karl Fischer ion chromatography wet chemistry and/or LC-MS

• Bachelors degree in Analytical Chemistry Chemistry Biochemistry Pharmaceutical Sciences or a related scientific discipline
• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience

• Approximately 5 years of relevant analytical laboratory experience preferably within a pharmaceutical or biopharmaceutical GMP environment

• Hands-on laboratory role; approximately 5060% hands-on laboratory work 2030% data processing/documentation and 1020% troubleshooting meetings training investigations and general laboratory responsibilities (may vary based on testing workload)
• Expected to work with a high degree of independence should be able to review a testing queue organize work execute established methods recognize unexpected results troubleshoot routine problems and appropriately escalate GMP or scientific issues without step-by-step direction

• Interview Process: Phone interview followed by a half-day group interview (in-person).
• Immediate start required.

• Medical Vision and Dental Insurance Plans
• 401k Retirement Fund

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking financial services technology life sciences biotech utilities and retail sectors throughout the U.S. and Canada.

Job Number: 26-13972

#LI-Onsite #gttic