Biologics Analytics & QC Director

zenasbio; Waltham (MA); Hybrid; USD 177,000 - 221,000; Full time

Benefits offered by this job

LI-Hybrid

Job summary

Zenas is seeking a Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods supporting biologics from early research through commercialization. As a key member of Technical Operations, the candidate will bring deep expertise in cell-based assays, leadership, and cross-functional collaboration in a fast-paced biotech environment.

You will partner with Process Development, Quality, Regulatory, and Manufacturing to ensure readiness

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Analytical Sciences, or a related field required; advanced degree preferred.
• 10+ years of relevant experience in analytical development within the biopharmaceutical or biotechnology industry.
• Strong background in biological cell-based assay method development.
• Experience in small-molecule analytical is a plus.
• Proven experience with method development, validation, and regulatory submissions.
• Deep understanding of ICH, FDA, and EMA regulatory requirements.
• Excellent communication, leadership, and organizational skills.
• Ability to manage multiple programs and priorities in a dynamic environment.

Responsibilities

• Develop and execute the analytical development strategy to support biologics product development across all stages (preclinical to commercial).
• Partner with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.
• Serve as a subject matter expert on key technical aspects of cell-based assay development, including protein conjugation, antibody screening, assay diluent formulation, preanalytical sample processing, scale-up, assay optimization, troubleshooting, data analysis, and analytical method validation.
• Oversee development, qualification validation and transfer of analytical methods for characterization, release, and stability testing.
• Guide analytical comparability studies and support tech transfer to internal and external manufacturing and QC labs.
• Provide oversight of deviations, OOS/OOT investigations, and root cause identification, ensuring timely resolution.
• Author and review analytical sections of regulatory filings (IND, IMPD, BLA, MAA).
• Ensure analytical methods and data meet regulatory expectations and ICH guidelines.
• Support CMC strategy, inspections, and audits.
• Serve as analytical development representative on project teams.
• Collaborate closely with discovery, process development, formulation, and quality teams to ensure robust product understanding.
• Evaluate and implement new technologies and analytical platforms to advance product characterization and process understanding.

Skills

Leadership

Analytical method development

Cell-based assay development

Regulatory submissions

ICH/FDA/EMA knowledge

Regulatory readiness

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Biochemistry/Analytical Sciences

Advanced degree preferred

Job description

Zenas is seeking a Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods supporting biologics from early research through commercialization. As a key member of Technical Operations, the candidate will bring deep expertise in cell-based assays, leadership, and cross-functional collaboration in a fast-paced biotech environment.

You will partner with Process Development, Quality, Regulatory, and Manufacturing to ensure readiness