Senior Bioanalytical Scientist
6 days ago
As a leading contract research organization, Pharmiweb 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 team in the LCMS Bioanalysis department is currently recruiting for a Method Development Specialist to join our dynamic team. The Method Development role is a lab-based position, where you will perform sample analysis of client's small molecule drug products.
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.
- 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.
- 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.
- 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.
- 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.
- A comprehensive training plan.
- 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.
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