Associate Director, Analytical Development and Quality Control (Small Molecules)
Zenas BioPharma•Waltham, MA
•$161,400 - $201,842•Hybrid
About The Position
The Associate Director of Analytical Development and Quality Control will lead the strategy, development, and execution of analytical methodologies to support small molecules product development from early research through commercialization. The ideal candidate will have deep scientific expertise in method development, QC oversight experience, and a proven ability to work cross-functionally in a fast-paced biotech environment.
Requirements
- Bachelors 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 and execute the analytical development strategy to support small molecules product development 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.
Benefits
- competitive compensation and benefits package
- annual performance bonus
- equity
- full range of benefits
- other incentive compensation plans
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
