[Hiring] Director, Bioanalytical Sciences @Bausch+Lomb Companies Inc.

Role Description

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.

Responsibilities

• 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 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.
• Leadership, compliance and budget
• Build, lead and mentor a team of scientists; set objectives, manage performance and foster a culture of scientific rigor and data integrity.
• Ensure externally conducted regulated bioanalysis complies with GLP, GCP, ICH M10 and Bausch + Lomb quality, data governance and EHS policies, and that internal non-GLP work operates to documented data-quality standards with non-GLP data clearly identified wherever reported.
• Manage departmental operating and capital budgets and resource planning; maintain awareness of emerging bioanalytical technologies and ocular-specific methodologies.

Qualifications

• Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology or a related discipline with 10+ years of industry experience; or M.S. with 14+; or B.S. with 16+.

Requirements

• Demonstrated bioanalytical leadership in pharmaceutical or biotechnology development spanning both small and large molecules / biologics, with hands-on or oversight expertise across LC-MS/MS and ligand-binding platforms.
• Track record in regulated bioanalysis (GLP) supporting IND, NDA and/or BLA submissions, including authorship of regulatory content.
• Substantial experience managing bioanalytical CROs as sponsor-side lead, accountable for outsourced data quality and defensibility.
• People leadership experience hiring and developing scientific staff; deep knowledge of ICH M10, FDA immunogenicity guidance and 21 CFR Part 11.

Benefits

• Eligible for short-term and/or long-term incentives.
• Participation in medical, dental, vision insurance, disability and life insurance.
• 401(k) plan and company match.
• Tuition reimbursement program (select degrees).
• Company holidays and well-being benefits.
• Eligible to receive sick time, floating holidays and paid vacation.