Research ScientistSenior Scientist LC-MSMS

We are seeking a Research Scientist / Senior Scientist to support the growth of our bioanalytical LC-MS/MS capabilities within a regulated CRO environment. This role will contribute to method development validation transfer and support sample analysis for a diverse range of therapeutic modalities including small molecules peptides oligonucleotides antibody-drug conjugates (ADCs) and monoclonal antibodies.

The successful candidate will bring hands-on experience in regulated bioanalysis and will work closely with scientific operational and quality teams to implement and execute assays in accordance with FDA EMA and ICH M10 addition to laboratory-based activities this individual will support SOP development equipment onboarding process improvement initiatives and the integration of LC-MS/MS services into an established bioanalytical testing organization.

This is an excellent opportunity for a scientifically mature and collaborative professional who enjoys both technical problem-solving and helping build new capabilities in a growing laboratory environment.

Heres what youll do:

• Develop optimize qualify and validate LC-MS/MS bioanalytical methods for regulated studies.
• Perform sample preparation instrument operation data analysis and troubleshooting.
• Support routine sample analysis for preclinical and clinical studies.
• Assist with assay validation activities in accordance with FDA EMA and ICH M10 guidance.
• Analyze and interpret data and contribute to study reports and technical documentation.
• Author and revise SOPs work instructions validation protocols and technical reports.
• Support onboarding qualification and maintenance of LC-MS/MS instrumentation and associated laboratory systems.
• Collaborate with cross-functional teams including Quality Assurance Operations Project Management and Scientific Leadership.
• Identify and implement opportunities for process improvements and operational efficiencies.
• Maintain compliance with applicable GLP GCP and company quality requirements.

Qualifications :

The ideal candidate:

• BS MS or PhD in Analytical Chemistry Biochemistry Pharmaceutical Sciences Chemistry or a related scientific discipline.
• 38 years of relevant bioanalytical laboratory experience.
• Hands-on experience with LC-MS/MS method development and validation.
• Working knowledge of FDA EMA and ICH M10 bioanalytical method validation requirements.
• Experience with one or more of the following analyte classes:
  • Small molecules
  • Peptides
  • Oligonucleotides
  • Antibody-drug conjugates (ADCs)
  • Monoclonal antibodies (mAbs)
• Experience supporting regulated bioanalytical studies and routine sample analysis.
• Strong technical writing and documentation skills.
• Excellent troubleshooting organizational and communication skills.
• Experience in a CRO pharmaceutical or biotechnology environment.
• Familiarity with hybrid LC-MS/LBA approaches.
• Experience with Waters Sciex Thermo Fisher or Shimadzu LC-MS/MS platforms.
• Experience supporting SOP development and laboratory process implementation.
• Experience with laboratory informatics systems including LIMS and chromatography data systems.
• Knowledge of assay validation sample management and regulated study workflows.

Additional Information :

The position is full-time Monday-Friday 8 a.m.- 5 p.m. with overtime as needed. Candidates within a commutable distance of Lenexa KS are encouraged to apply.  

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA Clinical Trial Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time