Associate Director, Analytical Development & QC—Small Molecules

Zenas BioPharma; Waltham (MA); On-site; USD 161,000 - 202,000; Full time

Job summary

Zenas BioPharma is seeking an Associate Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods supporting small molecule product development from research to commercialization.

The ideal candidate has deep expertise in method development, QC oversight, and cross-functional collaboration in a fast-paced biotech environment, with a strong track record in regulatory filings and ICH guidelines.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Analytical Sciences, or related field required; advanced degree preferred
• 8+ years of relevant experience in analytical development within the biopharmaceutical or biotechnology industry.
• Strong background in solid oral dosage method development.
• Experience in biologics 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 analytical development strategy to support small molecules across all stages (preclinical to commercial).
• Partner with Process Development, Quality, Regulatory, and Manufacturing to ensure analytical readiness and compliance.
• 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.
• Author and review analytical sections of regulatory filings (IND, IMPD, NDA, 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

Analytical development

Method development

Regulatory submissions

Cross-functional leadership

Quality oversight

Education

Bachelor's degree in Chemistry/Biochemistry/Analytical Sciences

8+ years analytical development experience

Tools

LC-MS

HPLC

Job description

Zenas BioPharma is seeking an Associate Director of Analytical Development and Quality Control to lead strategy, development, and execution of analytical methods supporting small molecule product development from research to commercialization.

The ideal candidate has deep expertise in method development, QC oversight, and cross-functional collaboration in a fast-paced biotech environment, with a strong track record in regulatory filings and ICH guidelines.