Sr. Associate Scientist (UHPLC, GxP)

Infotree Global Solutions; Thousand Oaks (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Infotree Global Solutions in Thousand Oaks, CA seeks a GMP analytical testing professional with a Bachelor's degree in Analytical Chemistry and about 5 years of experience to perform method execution and data integrity in support of pharmaceutical GMP testing.

The role emphasizes hands-on lab work (50–60%), data processing, and timely documentation, with independence to troubleshoot instrumentation and adhere to approved procedures.

Qualifications

• Bachelor's degree in Analytical Chemistry or related field with strong GMP knowledge.
• Approximately 5 years of relevant analytical lab experience in pharma/biopharma GMP.
• Experience performing analytical testing on synthetic pharmaceutical materials preferred.
• Understanding GMP, data integrity, and documentation practices.
• Ability to independently execute procedures and troubleshoot instrumentation.

Responsibilities

• Perform GMP analytical testing on drug substances/products and related materials.
• Document work contemporaneously and ensure data traceability.
• Troubleshoot instrumentation and chromatographic issues as they arise.
• Support method transfers, validations, and instrument qualifications as needed.
• Maintain lab equipment and ensure compliance with GMP requirements.

Skills

Independent work

Analytical testing

Data processing

Troubleshooting

Education

Bachelor's in Analytical Chemistry

PhD / MSc with experience

GMP laboratory experience

Tools

HPLC/UPLC

GC

KF

FTIR

UV-Vis

LC-MS

Job description

• 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.

Day to Day Responsibilities:

• For this GMP synthetic testing role, I’d expect the day-to-day to be much more hands-on in the lab than the original generic job description suggests. A typical day could look like:
• Start of day: Review assigned GMP samples, testing priorities, specifications, methods, and due dates. Confirm instruments, standards, reagents, columns, and other materials are available and within their appropriate use periods.
• Laboratory testing: Spend a significant portion of the day performing analytical testing on synthetic drug substance, drug product, stability, or related samples. This could include HPLC/UPLC, GC, KF, FTIR, UV-Vis, dissolution, IC, wet chemistry, or LC-MS, depending on the laboratory.
• Sample and solution preparation: Prepare standards, mobile phases, reagents, samples, and system suitability solutions according to approved methods and procedures.
• Instrument operation: Set up sequences, verify instrument readiness, perform system suitability, monitor runs, and respond to instrument or chromatography issues.
• GMP documentation: Document work contemporaneously in the appropriate laboratory notebook or electronic system, including reagent/standard information, calculations, instrument references, observations, deviations from expected execution, and testing results.
• Data processing and review: Process chromatographic or other analytical data, perform calculations, assess system suitability, compare results against specifications, and ensure the data package is complete and traceable.
• Troubleshooting: Investigate unexpected chromatography, instrument errors, preparation issues, system suitability failures, or atypical results. Determine what can be resolved independently and what needs to be escalated.
• Quality events/investigations: When something goes wrong, immediately preserve the relevant information and support laboratory events, deviations, investigations, or retesting activities in accordance with GMP procedures rather than simply repeating an experiment.
• Method/validation work: Depending on workload, support method transfers, qualifications, validations, instrument qualifications, or implementation of new analytical procedures.
• Lab operations: Maintain instruments and laboratory areas, manage standards/reagents, coordinate instrument availability, and ensure the laboratory remains inspection-ready.
• Team interaction: Attend brief huddles or project meetings to communicate sample status, testing timelines, instrument issues, investigations, and risks that could affect deliverables.
• For someone with a Bachelor’s degree and ~5 years of experience, I would also expect a higher degree of independence. They shouldn't require step-by-step direction for routine GMP testing. They should be able to look at their testing queue, organize their work, execute established methods, recognize when something doesn't look right, troubleshoot routine problems, and appropriately escalat e potential GMP or scientific issues.
• A realistic split might be roughly 50–60% hands-on laboratory work, 20–30% data processing/documentation, and 10–20% troubleshooting, meetings, training, investigations, and general laboratory responsibilities, although that could vary significantly depending on the testing workload.

Qualifications

• Bachelor’s degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Approximately 5 years of relevant analytical laboratory experience, preferably within a pharmaceutical or biopharmaceutical GMP environment.
• Experience performing analytical testing of synthetic pharmaceutical materials is strongly preferred.
• 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.

Basic Qualifications

• Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience