Director, Analytical Development and Quality Control
Zenas BioPharma • Waltham, MA61d • $176,900 - $221,219 • Hybrid
Quality Director Jobs
1,182 jobs found — updated daily
Associate Director, Analytical Development and Quality Control (Small Molecules)
Zenas BioPharma • Waltham, MA61d • $161,400 - $201,842 • HybridDeputy Director, City Environmental Quality Review (CEQR)
City of New York • New York, NY61d • $130,000 - $140,452 • OnsiteAssociate Director, Quality Auditing & Compliance
Ardelyx • Waltham, MA62d • HybridAssociate Director, R&D Quality Engineering
Boston Dynamics • Waltham, MA62d • $155,000 - $195,000Director of Quality, Integrity & Oversight
Project Hospitality • New York, NY62d • $70,000 - $80,000 • OnsiteDirector, Clinical Quality Assurance
Cytokinetics • South San Francisco, CA62d • $222,480 - $259,560 • HybridQuality Director
Red Tree Engineering62d • RemoteDirector, Engineering Services, Regulatory Affairs and Quality
Broan-NuTone • Hartford, WI62d • HybridExecutive Medical Director, Medical Group Surgical Quality
Endeavor Health • Evanston, IL62d • $365,400 - $455,200 • HybridDirector of Continuous Improvement & Quality
American Leather Operations LLC • Dallas, TX62dDirector, Quality Assurance Nuclear
CB&I • Plainfield, IL62dDirector, Quality & Compliance - PACE
San Ysidro Health • San Diego, CA62d • $70 - $93Associate Director, Quality Auditing & Compliance
Ardelyx • Waltham, MA63d • $188,000 - $230,000 • HybridDirector of Quality
Kaniksu Community Health • Sandpoint, ID63dDirector, GTS Quality Systems
BeiGene • Hopewell, NJ63d • $172,500 - $232,500 • RemoteAssociate Director, Quality Medical Device Engineer
Celldex Therapeutics • Hampton, NJ63d • $153,616 - $199,501 • OnsiteAssociate Director, Chemical Engineering
Nurix • Brisbane, CA63d • OnsiteAssociate Director, Chemical Engineering
Nurix • Brisbane, CA64d • $189,800 - $216,700 • OnsiteDirector, Quality Operations
PCI Pharma Services • Bedford, NH64d • Onsite
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
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
Director
Job Search Resources
Build a Resume for Quality Director
The resume builder that gets results.
- Get clear feedback so you look as qualified as you are
- Align your resume with the job to get further in the process, faster
- Take the guesswork out of resume writing
