Director, Bioanalytical Sciences — Ocular PK/PD Strategy

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

Job summary

Bausch + Lomb is seeking a senior bioanalytical leader to shape strategy across small and large molecules, biomarkers and ADA/neutralizing antibody assessments. You will oversee outsourced bioanalysis, CRO governance, data quality and regulatory defensibility, with an eye toward establishing an internal non-GLP lab in the near term.

Responsibilities include defining integrated analytical plans, representing bioanalysis to cross-functional teams, and leading vendor selection, budgets and

Qualifications

• Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology or a related discipline with 10+ years of industry experience.
• Experience with LC-MS/MS and ligand-binding platforms.
• Track record in regulated bioanalysis (GLP) supporting IND, NDA and/or BLA submissions.

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 the tiered assay approach across portfolio discovery/exploratory, GLP-validated and GCP-compliant clinical bioanalysis.
• Author bioanalytical sections of regulatory documents and respond to health authority questions.
• Lead biomarker assay strategy from exploratory through validated target engagement and pharmacodynamics.
• Own the bioanalytical CRO landscape: identify, qualify, select and manage vendors; negotiate scope, timelines and budgets.
• If expanding internal lab, develop business case, capability roadmap and phased investment plan.

Skills

Bioanalytical leadership

LC-MS/MS

Ligand-binding

Regulatory content

CRO management

Team leadership

Education

Ph.D. in analytical chemistry

M.S. in analytical chemistry or related field

B.S. in related discipline

Tools

LIMS

qPCR/ddPCR

Chromatography data systems

Job description

Bausch + Lomb is seeking a senior bioanalytical leader to shape strategy across small and large molecules, biomarkers and ADA/neutralizing antibody assessments. You will oversee outsourced bioanalysis, CRO governance, data quality and regulatory defensibility, with an eye toward establishing an internal non-GLP lab in the near term.

Responsibilities include defining integrated analytical plans, representing bioanalysis to cross-functional teams, and leading vendor selection, budgets and