Head of Bioanalysis & Translational Sciences

Bausch + Lomb; Santa Fe (NM); On-site; USD 175,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement program

Paid holidays and well-being benefits

Job summary

Bausch + Lomb is seeking a senior bioanalytical leader to guide strategies across small and large molecules, oligos, and biomarkers. You will partner with Clinical Evidence, Translational Development and Research to ensure fit-for-purpose validation and regulatory readiness.

The role involves managing CROs, leading a team, and shaping internal capabilities while upholding GLP/GCP, ICH M10, and 21 CFR 11 standards to protect data integrity and compliance.

Qualifications

• Demonstrated bioanalytical leadership in pharmaceutical/biotech development spanning small and large molecules.
• Regulated bioanalysis (GLP) support for IND/NDA/BLA submissions and regulatory content.
• Experience managing bioanalytical CROs as sponsor-side lead with data quality ownership.
• People leadership: 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, translating questions into analytical plans.
• Author bioanalytical sections of INDs/NDAs/BLAs and support regulatory interactions.
• Oversee CRO landscape, scope, budgets and vendor performance with GLP/GCP alignment.
• Lead internal lab build and future capability roadmap if approved.

Skills

Bioanalytical leadership

GLP/GCP experience

CRO management

Regulatory submissions

Data integrity

Leadership ability

Education

Ph.D. in analytical chemistry, biochemistry, pharmaceutical sciences, pharmacology, immunology or related

M.S. with 14+ years of industry experience

B.S. with 16+ years

Tools

LC-MS/MS

Ligand-binding assays

qPCR/ddPCR

LIMS

Data governance systems

Job description

Bausch + Lomb is seeking a senior bioanalytical leader to guide strategies across small and large molecules, oligos, and biomarkers. You will partner with Clinical Evidence, Translational Development and Research to ensure fit-for-purpose validation and regulatory readiness.

The role involves managing CROs, leading a team, and shaping internal capabilities while upholding GLP/GCP, ICH M10, and 21 CFR 11 standards to protect data integrity and compliance.