Director, Bioanalytical Sciences

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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.

Bioanalytical work is currently fully outsourced. The position owns that externalized model end to end — strategy, contract research organization (CRO) selection and governance, and accountability for data quality and regulatory defensibility. Should capital investment be approved, the position is expected to lead the establishment of an internal non-GLP bioanalytical laboratory within approximately the next two years, without interrupting program support.

Bioanalytical strategy and program support

• 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.

Biomarkers and translational analytics

• 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.

External partner (CRO) governance

• 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.

Internal non-GLP laboratory build (anticipated)

• With management, develop the business case, capability roadmap and phased investment plan for the internal laboratory, including…