Director, Bioanalytical Sciences & Translational Leader

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

Benefits offered by this job

Incentives

Health insurance

401(k) plan

Tuition reimbursement

Job summary

Bausch + Lomb seeks a senior bioanalytical leader to define cross-modal strategies, oversee CRO partnerships, and drive internal laboratory capability planning. You will influence GLP/GCP-compliant programs and author regulatory content for INDs/NDA/BLA submissions.

The role requires deep expertise in LC-MS/MS and ligand-binding platforms, with leadership experience and a track record of delivering regulated bioanalysis in pharmaceutical development.

Qualifications

• Experience leading bioanalytical programs across small molecules and biologics.
• Track record supporting IND/NDA/BLA with regulatory content.
• Experience managing bioanalytical CROs as sponsor-side lead.
• Leadership in hiring and developing scientific staff.
• Knowledge of ICH M10 and 21 CFR Part 11.

Responsibilities

• Define and own integrated bioanalytical strategies across modalities and matrices.
• Represent bioanalysis on cross-functional teams and regulatory interactions.
• Oversee external CRO governance and vendor performance.
• Plan and lead internal non-GLP lab build if approved.
• Mentor scientists and ensure data integrity and compliance.

Skills

Bioanalysis leadership

LC-MS/MS

Ligand-binding assays

Regulatory submissions

People leadership

CRO management

Education

PhD in analytical chemistry / biochemistry / pharmaceutical sciences (or related)

MS with 14+ years of experience

BS with 16+ years of experience

Tools

LIMS

Chromatography data systems

Job description

Bausch + Lomb seeks a senior bioanalytical leader to define cross-modal strategies, oversee CRO partnerships, and drive internal laboratory capability planning. You will influence GLP/GCP-compliant programs and author regulatory content for INDs/NDA/BLA submissions.

The role requires deep expertise in LC-MS/MS and ligand-binding platforms, with leadership experience and a track record of delivering regulated bioanalysis in pharmaceutical development.