Director, Bioanalytical Sciences

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.

We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

To provide scientific and strategic leadership for all bioanalysis supporting Bausch + Lomb ocular therapeutic programs, from discovery through registration and lifecycle management, across small molecule and large molecule modalities.

• Define and own integrated bioanalytical strategies across small and large molecules, oligonucleotides, biomarkers and anti-drug antibody (ADA) / neutralizing antibody assessment, selecting platforms appropriate to each modality and matrix (LC-MS/MS, ligand-binding assays, hybrid LC-MS, qPCR/ddPCR).
• Represent bioanalysis on cross-functional program teams, translating program questions (dose selection, ocular and systemic exposure, PK/PD, target engagement) into fit-for-purpose analytical plans.
• Establish the tiered assay approach across the portfolio — discovery/exploratory, GLP-validated and GCP-compliant clinical bioanalysis — with clear criteria for the level of validation rigor applied at each stage.
• Author the bioanalytical sections of INDs, IMPDs and NDAs/BLAs, respond to health authority questions, and represent bioanalysis in regulatory interactions and inspections.

• Lead biomarker assay strategy from exploratory through validated — target engagement, pharmacodynamics, disease progression and patient selection — partnering with Clinical Evidence, Translational Development and Research on fit-for-purpose validation and context of use.

• Own the bioanalytical CRO landscape: identify, technically qualify, select and manage vendors across modalities and geographies, and negotiate scope, timelines and budgets with Procurement.
• Provide scientific oversight of outsourced method development, validation and sample analysis — reviewing protocols, reports and data and approving deviations and investigations — and monitor partner performance against quality, turnaround and incurred sample reanalysis metrics consistent with GLP and GCP expectations.

• With management, develop the business case, capability roadmap and phased investment plan for the internal laboratory, including make-versus-buy analysis and modality prioritization.
• If approved, lead design and execution: facility fit-out, instrument selection, LIMS and chromatography data system architecture with data integrity and access controls appropriate to a non-GLP research environment, and sample management.
• Recruit, onboard and develop the internal scientific team, and define the enduring hybrid model of internal capability combined with strategic outsourcing.

• Build, lead and mentor a team of…