Head of LBA Bioanalysis
GSK
3 days ago
On-site
Collegeville, PA
Clinical Research and Development
Position Summary
- Lead the Ligand Binding Assay (LBA) bioanalysis function in Bioanalytical and Biomarker Platforms (BBP).
- Own development, validation, and execution of high-quality bioanalytical assays with data integrity, regulatory compliance, and timely delivery across the GSK Biopharm portfolio.
- Set scientific direction and partner with drug development teams.
Responsibilities
- Head the LBA PK group; manage 5–6 lab scientists, including workload planning, resource allocation, and prioritization across multiple programs.
- Drive LBA PK bioanalytical strategy aligned to study phase, regulatory expectations, and scientific objectives.
- Lead LBA PK assay development, validation, and sample analysis for early-stage clinical programs.
- Support transfer of LBA PK assays to external CROs for late-stage support; troubleshoot CRO assays.
- Evaluate and optimize/re-develop LBA PK assays for in-licensed assets.
- Define bioanalytical plans/timelines/deliverables with project teams; provide LBA PK scientific input for decisions and risk assessments.
- Ensure GLP/GCP, SOP, and data integrity compliance; support audits, inspections, and regulatory submissions.
- Lead, mentor, and develop bioanalytical scientists/matrix contributors.
- Contribute to long-term bioanalysis/biomarker strategy; drive continuous improvement and innovation.
Basic Qualifications (Required)
- PhD (Biology/Biochemistry/related) + 8 years industry ligand-binding bioanalysis; or M.S. + 15 years.
- Leadership experience in regulated environments.
- LBA experience (e.g., ELISA, MSD) and bioanalytical problem-solving.
- Ability to lead complex programs and influence cross-functional teams; PK assay strategy with clinical pharmacology.
- Hands-on experience with data management systems and LIMS.
Preferred Qualifications
- Experience managing CRO/vendor partnerships and ensuring data quality/compliance.
- Broader bioanalytical strategy (PK, biomarkers, immunogenicity).
- Experience with oligonucleotides and/or complex modalities (e.g., ADCs).
- Familiarity with bioanalysis regulatory submissions/queries.
- Experience with lab transformation (digitalization, automation, analytics-driven QC).
Work Arrangement
- Expected on-site to support lab operations and team leadership; some remote flexibility.
Application
- Apply and describe how your experience and approach will help advance drug development.
- Lead the Ligand Binding Assay (LBA) bioanalysis function in Bioanalytical and Biomarker Platforms (BBP).
- Own development, validation, and execution of high-quality bioanalytical assays with data integrity, regulatory compliance, and timely delivery across the GSK Biopharm portfolio.
- Set scientific direction and partner with drug development teams.
Responsibilities
- Head the LBA PK group; manage 5–6 lab scientists, including workload planning, resource allocation, and prioritization across multiple programs.
- Drive LBA PK bioanalytical strategy aligned to study phase, regulatory expectations, and scientific objectives.
- Lead LBA PK assay development, validation, and sample analysis for early-stage clinical programs.
- Support transfer of LBA PK assays to external CROs for late-stage support; troubleshoot CRO assays.
- Evaluate and optimize/re-develop LBA PK assays for in-licensed assets.
- Define bioanalytical plans/timelines/deliverables with project teams; provide LBA PK scientific input for decisions and risk assessments.
- Ensure GLP/GCP, SOP, and data integrity compliance; support audits, inspections, and regulatory submissions.
- Lead, mentor, and develop bioanalytical scientists/matrix contributors.
- Contribute to long-term bioanalysis/biomarker strategy; drive continuous improvement and innovation.
Basic Qualifications (Required)
- PhD (Biology/Biochemistry/related) + 8 years industry ligand-binding bioanalysis; or M.S. + 15 years.
- Leadership experience in regulated environments.
- LBA experience (e.g., ELISA, MSD) and bioanalytical problem-solving.
- Ability to lead complex programs and influence cross-functional teams; PK assay strategy with clinical pharmacology.
- Hands-on experience with data management systems and LIMS.
Preferred Qualifications
- Experience managing CRO/vendor partnerships and ensuring data quality/compliance.
- Broader bioanalytical strategy (PK, biomarkers, immunogenicity).
- Experience with oligonucleotides and/or complex modalities (e.g., ADCs).
- Familiarity with bioanalysis regulatory submissions/queries.
- Experience with lab transformation (digitalization, automation, analytics-driven QC).
Work Arrangement
- Expected on-site to support lab operations and team leadership; some remote flexibility.
Application
- Apply and describe how your experience and approach will help advance drug development.