Senior Scientist Associate - UHPLC
- πΊπΈ United States
- On-site
- Senior
- 4 weeks ago
- GMP
- GxP
- Pension
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Scientist Senior Associate - UHPLC
Location: Thousand Oaks, CA
Onsite Flexibility: Onsite
Contract Details
- Position Type: Contract
- Contract Duration: 6 months
- Pay Rate: $30.00β$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.
Job Summary
PerformGMP 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.
Key Responsibilities
- 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.
Required Skills
- 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
Preferred Skills
- 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
Education Requirements
- Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
- Doctorate degree OR Master's degree and 2 years of experience OR Bachelor's degree and 4 years of experience
Required Experience
- Approximately 5 years of relevant analytical laboratory experience, preferably within a pharmaceutical or biopharmaceutical GMP environment
Work Environment / Physical Requirements
- Hands-on laboratory role; approximately 50β60% hands-on laboratory work, 20β30% data processing/documentation, and 10β20% troubleshooting, meetings, training, investigations, and general laboratory responsibilities (may vary based on testing workload)
- Expected to work with a high degree of independence β 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
Important Notes
- Interview Process: Phone interview, followed by a half-day group interview (in-person).
- Immediate start required.
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About GTT
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
Senior Scientist Associate - UHPLC Β· GTT, LLC