Bioanalytical Chemistry Director — Lab Leadership

CBSET, Inc.; Lexington (MA); Hybrid; USD 150,000 - 225,000; Full time

Job summary

CBSET, Inc. seeks a Director of Bioanalytical Chemistry to lead bioanalytical strategy, lab operations, and regulatory adherence for drug development. You will manage scientists, design and validate assays (PK, ADA, biomarkers), and ensure data integrity across GLP/GCP studies.

The role requires advanced degrees and 15+ years in bioanalytical labs, with 5+ years in leadership. Strong cross-functional collaboration and budget oversight are essential in this senior leadership position.

Qualifications

• 15+ years in bioanalytical sciences within biopharma, with 5+ years in scientific leadership in regulated environment.
• Deep expertise in LC-MS/MS, ELISA, and related bioanalytical techniques.
• Strong knowledge of GLP/GCP, 21 CFR Part 11, and global regulatory landscape.
• Experience managing CROs and internal bioanalytical teams, with budget oversight.

Responsibilities

• Lead bioanalytical teams and guide strategic decisions.
• Oversee design, validation, and comparison of PK, PD, and biomarker assays using LC-MS/MS and immunoassays.
• Ensure GLP/GCP compliance and data integrity across studies.
• Collaborate with project management, regulatory affairs, and external partners to drive programs.
• Mentor staff and manage departmental budgets and staffing plans.

Skills

Leadership

Regulatory compliance

Project management

Communication

Bioanalytical methods

Education

PhD in analytical chemistry or related field

MS or BS with 15+ years experience

Tools

LC-MS/MS

ELISA

LIMS

Immunoassays

Job description

CBSET, Inc. seeks a Director of Bioanalytical Chemistry to lead bioanalytical strategy, lab operations, and regulatory adherence for drug development. You will manage scientists, design and validate assays (PK, ADA, biomarkers), and ensure data integrity across GLP/GCP studies.

The role requires advanced degrees and 15+ years in bioanalytical labs, with 5+ years in leadership. Strong cross-functional collaboration and budget oversight are essential in this senior leadership position.