Analytical Development & QC Lead - Associate Director

zenasbio; Waltham (MA); Hybrid; USD 161,000 - 202,000; Full time

Benefits offered by this job

Annual bonus

Equity

Full benefits package

Job summary

Zenas is a clinical-stage biopharmaceutical company seeking an Associate Director of Analytical Development and Quality Control to lead the strategy, development, and execution of analytical methodologies supporting small molecules from early research through commercialization.

The ideal candidate will drive cross-functional collaboration, QC oversight, and regulatory submissions in a fast-paced biotech setting.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 8+ years of relevant analytical development experience in biopharma.
• Solid oral dosage method development expertise.
• Experience with regulatory submissions and ICH/FDA/EMA guidelines.
• Biologics analytical experience is a plus.

Responsibilities

• Develop and execute the analytical development strategy for small molecules across all stages.
• Partner with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness.
• Oversee method development, qualification, validation and transfer.
• Author and review analytical sections of regulatory filings (IND, IMPD, NDA, MAA).
• Ensure methods meet regulatory expectations and ICH guidelines.
• Support CMC strategy, inspections, and audits.
• Serve as analytical development representative on project teams.
• Collaborate with discovery, process development, formulation, and quality teams.
• Evaluate and implement new technologies for product characterization.

Skills

Analytical development

Regulatory submissions

Cross-functional leadership

ICH FDA EMA knowledge

Communication skills

Project management

Education

Bachelor's degree in Chemistry, Biochemistry, Analytical Sciences, or related field

Job description

Zenas is a clinical-stage biopharmaceutical company seeking an Associate Director of Analytical Development and Quality Control to lead the strategy, development, and execution of analytical methodologies supporting small molecules from early research through commercialization.

The ideal candidate will drive cross-functional collaboration, QC oversight, and regulatory submissions in a fast-paced biotech setting.