Director, Bioanalytical Sciences — Eye Health Bioanalysis Leader

Bausch + Lomb; Juneau (AK); On-site; USD 175,000 - 240,000; Full time

Job summary

Bausch + Lomb is seeking a senior bioanalytical leader to drive integrated strategies for small and large molecules across discovery to lifecycle management. You will chair cross-functional teams, oversee GLP-validated and regulatory submissions, and manage CRO partnerships to ensure data quality and compliance.

The role requires a PhD or equivalent in a related field with extensive industry experience, strong leadership, and a track record in regulated bioanalysis within the ophthalmic or

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+.
• 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 11.

Responsibilities

• Define and own integrated bioanalytical strategies across small and large molecules, oligonucleotides, biomarkers and ADA/neutralizing antibody assessment.
• Represent bioanalysis on cross-functional program teams, translating program questions into fit-for-purpose analytical plans.
• Establish tiered assay approach across discovery, GLP-validated and GCP-compliant clinical bioanalysis.
• Author bioanalytical sections of INDs, IMPDs and NDAs/BLAs; respond to health authority questions and regulatory interactions.
• Own the bioanalytical CRO landscape: identify, qualify, select, and manage vendors across modalities and geographies.

Skills

Bioanalytical leadership

Regulated bioanalysis (GLP)

CRO management

LC-MS/MS

Immunogenicity knowledge

Data integrity

Education

PhD in analytical chemistry / related

MS in related field

BS in related field

Tools

LC-MS/MS

Ligand-binding assays

qPCR/ddPCR

LIMS

Chromatography data system

Job description

Bausch + Lomb is seeking a senior bioanalytical leader to drive integrated strategies for small and large molecules across discovery to lifecycle management. You will chair cross-functional teams, oversee GLP-validated and regulatory submissions, and manage CRO partnerships to ensure data quality and compliance.

The role requires a PhD or equivalent in a related field with extensive industry experience, strong leadership, and a track record in regulated bioanalysis within the ophthalmic or