Director, Bioanalytical Sciences — Eye Health Innovator

Bausch + Lomb; Phoenix (AZ); Presencial; USD 175.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance incentives

Medical, dental, vision insurance

401(k) with company match

Tuition reimbursement

Descripción de la vacante

Bausch + Lomb is seeking a senior bioanalytical leader to guide strategy across small molecules and biologics for ocular programs. The role includes governing outsourced bioanalysis to CROs, ensuring data quality and regulatory defensibility, and planning an internal non-GLP lab if approved.

The position requires extensive GLP/GCP experience, leadership skills, and deep familiarity with ICH M10 and 21 CFR Part 11.

Formación

• Bioanalytical leadership across small molecules, biologics, and ocular modalities.
• Experience with GLP-regulated bioanalysis supporting IND/NDA/BLA.
• Experience managing CROs and outsourcing with data quality focus.
• Deep knowledge of ICH M10, FDA immunogenicity guidance, and 21 CFR Part 11.

Responsabilidades

• Define and own integrated bioanalytical strategies across modalities and matrices.
• Represent bioanalysis on cross-functional teams and translate program questions into analytical plans.
• Lead CRO landscape: qualify, select, and manage vendors with budgets and timelines.
• Plan and potentially lead an internal non-GLP bioanalytical lab with a hybrid model.

Conocimientos

Bioanalytical leadership

GLP/GCP experience

CRO management

Regulatory content authorship

ICH M10 / 21 CFR Part 11 knowledge

Educación

Ph.D. in analytical chemistry / related field

M.S. in analytical chemistry / related field

B.S. in analytical chemistry / related field

Herramientas

LC-MS/MS

Ligand-binding assays

Hybrid LC-MS

qPCR / ddPCR

Descripción del empleo

Bausch + Lomb is seeking a senior bioanalytical leader to guide strategy across small molecules and biologics for ocular programs. The role includes governing outsourced bioanalysis to CROs, ensuring data quality and regulatory defensibility, and planning an internal non-GLP lab if approved.

The position requires extensive GLP/GCP experience, leadership skills, and deep familiarity with ICH M10 and 21 CFR Part 11.