About LabCorp Drug Development:
As a leading contract research organization, LabCorp provides comprehensive drug development solutions for a range of industries. We are a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Together with our clients, we support the development of innovative, life-changing treatments.
The Role:
Our largest UK site in Harrogate, is currently recruiting for a Method Development Specialist to join the LCMS Bioanalysis team.
The Method Development role is a lab based position. You will develop LCMS bioanalytical methods; that will then be validated and utilised by the operations team; to perform sample analysis of client's small molecule drug products. We are especially interested in candidates with high resolution MS experience as we expand our capabilities in this area.
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The successful candidate will join our dynamic team and focus on the development of regulatory-ready analytical methods for the quantification and characterization of both small and large molecules, including proteins, antibody-drug conjugates (ADCs) and biomarkers, using liquid chromatography-mass spectrometry (LC/MS) and high-resolution mass spectrometry (HRMS). These methods will be transferred to validation and used in support of regulatory submissions.
Key Responsibilities:
- Develop, optimize, and prepare LC/MS and HRMS methods for regulatory readiness, ensuring they meet the required standards for validation and transfer.
- Perform method development for the bioanalysis of small molecules
- Perform both bottom-up and top-down method development for the bioanalysis of large molecules:
- Bottom-Up Method Development: Enzymatic digestion of proteins into peptides followed by LC/MS analysis for the identification, quantification, and characterization of proteins and post-translational modifications.
- Top-Down Method Development: Direct analysis of intact proteins and protein complexes using LC/MS to allow for detailed characterization of protein structure, including proteoforms and complex modifications.
- Collaborate with validation teams to ensure smooth method transfer and implementation.
- Troubleshoot and maintain LC/MS and HRMS instrumentation to ensure optimal performance.
- Stay current with advancements in LC/MS and HRMS technology and bioanalytical techniques, applying best practices to enhance lab efficiency and capabilities.
Key Qualifications:
- 5+ years of hands-on experience with LC/MS, specifically in the development of methods for the analysis of large molecules such as proteins and ADCs.
- Expertise in high-resolution mass spectrometry (HRMS) and its application alongside standard LC/MS workflows.
- Extensive experience in bottom-up and top-down method development for large molecule bioanalysis.
- Proficiency in developing methods that are regulatory-ready and can be seamlessly transferred to validation.
- Strong understanding of regulatory requirements and guidelines (e.g., ICH M10) for bioanalytical method validation.
- Proficiency in sample preparation techniques for both small and large molecules, including immunoaffinity capture, solid-phase extraction, and protein precipitation.
- Proven track record in method development and troubleshooting of LC/MS and HRMS assays for both small and large molecule bioanalysis.
- Proficiency in data analysis software and statistical tools commonly used in bioanalysis.
- Excellent problem-solving skills, attention to detail, and ability to work independently as well as part of a team.
- Strong communication skills, with the ability to effectively convey complex scientific information to both technical and non-technical audiences.
- Knowledge of biopharmaceutical development processes and regulatory expectations for bioanalysis
- Previous experience in a GLP & GCP bioanalysis -compliant environment.
What LabCorp Drug Development can offer you:
- A comprehensive training plan; with the ability to develop your technical and managerial skills.
- Unsurpassed career development opportunities.
- Ability to work with a variety of different clients on wide ranging projects.
- Competitive salaries and a comprehensive benefits package including health cover and contributory pension.
- Relocation assistance if applicable
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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