Bioanalysis Strategy Lead – Ophthalmic Outsourcing

Bausch + Lomb; Trenton (NJ); Sur place; USD 175 000 - 240 000; Plein temps

Avantages offerts par ce poste

Incentives

Medical Insurance

401(k) with company match

Tuition Reimbursement

Paid Vacation

Résumé du poste

Bausch + Lomb in New Jersey seeks a senior bioanalytical leader to drive strategy across small molecules, biologics and biomarkers. You will own CRO governance, ensure regulatory defensibility, and guide data quality from discovery through lifecycle management.

Lead external partners, influence cross-functional teams, and contribute to the plan for an internal non-GLP lab. Requires 10+ years in bioanalysis with a PhD or equivalent and strong regulatory experience.

Qualifications

• Ph.D. in analytical chemistry or related field with 10+ years in industry.
• Proven bioanalytical leadership spanning small molecules and biologics.
• Experience with GLP and regulatory submissions (IND/NDA/BLA).

Responsabilités

• Define and own integrated bioanalytical strategies across modalities.
• Represent bioanalysis on cross-functional program teams and translate questions into analytical plans.
• Own CRO landscape: identify, qualify, and manage vendors; negotiate scope, timelines and budgets.
• Lead internal non-GLP laboratory build (if approved) and establish data-integrity standards.

Connaissances

Bioanalytical leadership

GLP/GCP experience

CRO management

LC-MS/MS

Ligand-binding assays

Regulatory strategy

Formation

PhD in analytical chemistry / related field

MS in related field

BS with extensive experience

Outils

LIMS

qPCR/ddPCR

Mass spectrometry

Description du poste

Bausch + Lomb in New Jersey seeks a senior bioanalytical leader to drive strategy across small molecules, biologics and biomarkers. You will own CRO governance, ensure regulatory defensibility, and guide data quality from discovery through lifecycle management.

Lead external partners, influence cross-functional teams, and contribute to the plan for an internal non-GLP lab. Requires 10+ years in bioanalysis with a PhD or equivalent and strong regulatory experience.