Remote Director, Bioanalytical Sciences (GLP/GCP)

Scorpion Therapeutics; United States; Remote; USD 220,000 - 300,000; Full time

Job summary

Bausch + Lomb seeks a senior leader to drive bioanalysis strategy across discovery to lifecycle management for ocular therapeutics. You will shape assay development for PK/PD, engage in regulatory submissions, and manage CROs while guiding a scientific team under GLP/GCP frameworks.

The role emphasizes internal lab development planning, regulatory interactions, and cross-functional collaboration with a focus on US remote work flexibility.

Qualifications

• Ph.D. with 10+ years in regulated bioanalysis for IND/NDA/BLA programs.
• Expertise in LC-MS/MS, ligand-binding assays, and immunogenicity.
• Experience managing CROs and regulatory interactions.

Responsibilities

• Define and oversee bioanalytical strategies including assay development for PK/PD, target engagement, and immunogenicity.
• Author regulatory submissions and responses.
• Oversee CRO selection and management; lead potential internal non-GLP lab build.
• Ensure compliance with GLP, GCP, and ICH standards.
• Mentor scientific team and manage budgets.

Skills

Leadership

Strategic thinking

Regulatory science

Budget management

Team mentorship

Education

Ph.D. in analytical chemistry or biochemistry

Tools

LC-MS/MS

Ligand-binding assays

Immunogenicity assessments

CRO management

Regulatory submissions

Job description

Bausch + Lomb seeks a senior leader to drive bioanalysis strategy across discovery to lifecycle management for ocular therapeutics. You will shape assay development for PK/PD, engage in regulatory submissions, and manage CROs while guiding a scientific team under GLP/GCP frameworks.

The role emphasizes internal lab development planning, regulatory interactions, and cross-functional collaboration with a focus on US remote work flexibility.