Director, Bioanalytical Strategy & Outsourced Bioanalysis

Bausch & Lomb GmbH; Northern (KY); Hybrid; USD 175,000 - 240,000; Full time

Benefits offered by this job

Remote work options

Competitive compensation

Job summary

Bausch + Lomb is seeking a senior bioanalytical leader for an integrated strategy across small and large molecules. You will own CRO governance, drive validation plans, and align bioanalysis with regulatory expectations while building internal capabilities.

The role emphasizes leadership, data integrity, and strategic outsourcing with potential internal lab development. Remote US-based location is possible.

Qualifications

• Demonstrated bioanalytical leadership in pharma/biotech development.
• Experience with GLP-regulated bioanalysis for IND/NDA/BLA.
• Experience managing CROs as sponsor-side lead.
• Strong understanding of ICH M10, FDA immunogenicity guidance.

Responsibilities

• Define and own integrated bioanalytical strategies across modalities.
• Represent bioanalysis on cross-functional program teams and translate questions into plans.
• Establish tiered assay approach with clear validation criteria.
• Author bioanalytical sections of regulatory documents and respond to agency questions.

Skills

Bioanalysis leadership

LC-MS/MS expertise

Regulated bioanalysis

CRO management

Team leadership

Education

PhD in analytical chemistry / related

MS in related field

BS in related field

Tools

LIMS

Job description

Bausch + Lomb is seeking a senior bioanalytical leader for an integrated strategy across small and large molecules. You will own CRO governance, drive validation plans, and align bioanalysis with regulatory expectations while building internal capabilities.

The role emphasizes leadership, data integrity, and strategic outsourcing with potential internal lab development. Remote US-based location is possible.