Remote Bioanalytical Sciences Director

Bausch+Lomb; United States; Remote; USD 175,000 - 240,000; Full time

Job summary

Bausch + Lomb is seeking a senior bioanalytical leader to drive scientific strategy and governance for ocular therapeutics. The role spans strategy across small and large molecules, biomarker and ADA assessment, and oversight of outsourced CROs.

You will draft regulatory-ready bioanalytical sections for INDs/NDAs, guide validation strategy, and coordinate with cross-functional teams to answer regulator questions. This remote US-based role emphasizes data integrity and quality.

Qualifications

• Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology or related; 10+ years of industry experience.
• Alternative: MS with 14+ years or BS with 16+ years of experience.

Responsibilities

• Define and own integrated bioanalytical strategies across small and large molecules, oligonucleotides, biomarkers and ADA/neutralizing antibodies.
• Represent bioanalysis on cross-functional program teams, translating program questions into analytical plans.
• Establish the tiered assay approach across discovery to clinical bioanalysis with appropriate validation.
• Author bioanalytical sections of INDs, IMPDs and NDAs/BLAs, and respond to health authority questions.

Skills

Bioanalytical leadership

GLP experience

CRO management

People leadership

Regulatory content authorship

Education

Ph.D. in analytical chemistry or related

Tools

LC-MS/MS

Ligand-binding assays

Job description

Bausch + Lomb is seeking a senior bioanalytical leader to drive scientific strategy and governance for ocular therapeutics. The role spans strategy across small and large molecules, biomarker and ADA assessment, and oversight of outsourced CROs.

You will draft regulatory-ready bioanalytical sections for INDs/NDAs, guide validation strategy, and coordinate with cross-functional teams to answer regulator questions. This remote US-based role emphasizes data integrity and quality.