Director, Biologics Analytics & QC Strategy

Zenas BioPharma; Waltham (MA); On-site; USD 177,000 - 221,000; Full time

Benefits offered by this job

Annual bonus

Equity

Job summary

Zenas BioPharma is seeking a Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods for biologics from early research through commercialization. You will work with cross-functional teams in a fast-paced biotech environment and drive regulatory-compliant analytics.

The role requires deep expertise in cell-based assays, leadership experience, and collaboration across Discovery, Process Development, and Quality.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Analytical Sciences, or related field.
• 10+ years of analytical development experience in biopharma/biotech.
• Strong background in biological cell-based assay method development.

Responsibilities

• Develop and implement the analytical development strategy for biologics from preclinical to commercial.
• Collaborate with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.
• Serve as SME for cell-based assay development, including conjugation, screening, formulation, sample processing, scale-up, and validation.
• Oversee method development, qualification, transfer, and stability testing.
• Guide comparability studies and support tech transfer to internal and external labs.
• Manage deviations, OOS/OOT investigations, and root cause identification.

Skills

Analytical development

Cell-based assays

Leadership

Regulatory submissions

Education

Bachelor's degree (Chemistry / Biochemistry / Analytical Sciences)

Master's or PhD preferred

Job description

Zenas BioPharma is seeking a Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods for biologics from early research through commercialization. You will work with cross-functional teams in a fast-paced biotech environment and drive regulatory-compliant analytics.

The role requires deep expertise in cell-based assays, leadership experience, and collaboration across Discovery, Process Development, and Quality.