Director, Analytical Development and Quality Control (Biologics)
Zenas BioPharma•Waltham, MA
•$176,900 - $221,219•Hybrid
About The Position
The Director of Analytical Development and Quality Control will lead the strategy, development, and execution of analytical methodologies to support biologics product development from early research through commercialization. As a key member of the Technical Operations team, the ideal candidate will have deep scientific expertise in cell-based assays, leadership experience, and a proven ability to work cross-functionally in a fast-paced biotech environment.
Requirements
- 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.
Benefits
- competitive compensation and benefits package
- annual performance bonus
- equity
- full range of benefits
- other incentive compensation plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
