Position Summary: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.
Key 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.
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.
#LI-Hybrid
The position is eligible for a competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $176,900 to $221,219. Actual compensation packages will depend on various factors, including, but not limited to, depth of experience, education, skillset, overall performance, and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy, which also includes an annual performance bonus, equity, a full range of benefits, and other incentive compensation plans.
