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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quantitative bioanalysis, drug development, and regulatory compliance, with a strong focus on managing outsourced bioanalytical activities and CRO relationships. Proven ability to lead complex projects, ensuring adherence to GLP and GCP standards while delivering high-quality results.
Highest-signal resume keywords
Quantitative BioanalysisLigand Binding Assays (LBA)LC-MS/MS AssaysImmunogenicity Testing (ADA, NAb)Good Laboratory Practice (GLP)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quantitative BioanalysisLigand Binding Assays (LBA)LC-MS/MS AssaysImmunogenicity Testing (ADA, NAb)Bioanalytical Method ValidationRegulatory SubmissionsProject ManagementBioanalytical StrategiesData Review and AnalysisSample Management
Soft Skills
Organizational SkillsProblem-Solving CapabilityCommunication SkillsInterpersonal SkillsCollaboration
Industry Keywords
Good Clinical Practice (GCP)Drug Development ProcessRegulatory GuidanceCRO ManagementBiologics
About the role
Key responsibilities & impact- Provide scientific and operational oversight of outsourced bioanalytical activities at CROs
- Lead drug and biomarker quantitation assays, including LBA and LC-MS/MS
- Oversee immunogenicity testing, including ADA and NAb
- Manage bioanalytical studies from planning through final reporting
- Interact with CROs and coordinate bioanalytical agreements and CRO documents
- Facilitate meetings with external laboratories to review progress, identify risks, and implement mitigation strategies
- Collaborate with internal teams to ensure bioanalysis meets project expectations
- Monitor CRO performance, deliverables, budgets, milestones, and contractual commitments
- Ensure method development, validation, and bioanalytical plans and reports meet regulatory expectations and project needs
- Review bioanalytical data and verify adherence to analysis and reporting schedules
- Troubleshoot scientific and operational issues and communicate risks and solutions to stakeholders
- Coordinate sample management, tracking, and shipment oversight
- Support regulatory submissions
- Evaluate CROs and source quantitative bioanalytical studies
- Act as Sourcing Manager for purchasing quantitative bioanalytics from CROs
- Build and maintain relationships with internal stakeholders and CROs
- Drive proactive problem solving and continuous improvement across outsourced bioanalytical activities
- Report to Head of Quantitative Bioanalytics & Biomarkers
Requirements
What you’ll need- At least MSc degree in a relevant scientific discipline with strong industry experience
- Extensive experience in quantitative bioanalysis and drug development, especially with biologics
- Strong understanding of the drug development process from discovery through regulatory submission and product approval
- Extensive experience with Ligand Binding Assays (LBA)
- Extensive experience with immunogenicity testing (ADA including NAb)
- Extensive experience with LC-MS/MS assays for large and small molecule therapeutics
- Experience with bioanalytical strategies supporting non-clinical and clinical development
- Demonstrated experience managing outsourced bioanalytical studies and CRO relationships
- Strong knowledge of Good Laboratory Practice (GLP)
- Strong knowledge of Good Clinical Practice (GCP)
- Strong knowledge of global regulatory guidance for bioanalytical method validation and immunogenicity assessment
- Experience supporting global development programs and international collaborations
- Excellent organizational and project management skills
- Strong scientific problem-solving capability
- Outstanding written and verbal communication skills
- Detail-oriented with a commitment to quality and compliance
- Strong interpersonal skills with the ability to influence and collaborate across multidisciplinary teams
- Proven ability to manage complex projects and deliver results under demanding timelines
- Willingness to travel domestically and internationally as required
- Must complete an approved medical examination including drug testing prior to employment
- Must pass security clearance prior to employment
Benefits
Comp & perks- Career paths and development opportunities
- Safe working environment
- Approved medical examination and drug testing prior to employment
- Security clearance prior to employment