Job Details
Onsite
Education/Experience: Bachelor s degree with approximately 5 years of relevant laboratory experience.
Position Summary
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.
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.
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.