Director of Quality Control

Director, Quality Control (QC)

Location: Cambridge, MA (Hybrid)

An innovative biotechnology company developing next-generation biologics and engineered fusion protein therapeutics focused on immune and autoimmune-driven diseases is seeking a Director of Quality Control. As multiple programs progress through IND-enabling studies and early clinical development, this leader will build and scale the QC function, ensure analytical excellence, and drive phase-appropriate GMP compliance across a growing modality portfolio.

• Build and lead a high-performing QC organization supporting a biologics and engineered fusion protein pipeline.
• Develop QC strategy aligned with IND-enablement, early-phase manufacturing, tech transfer, and later-stage readiness.
• Grow, mentor, and manage QC staff across analytical, microbiology, and sample management groups.
• Establish scalable QC systems and processes that evolve with increasing program complexity.

• Oversee analytical testing for biologics and fusion proteins including potency, purity, structural characterization, binding assays, and cell-based functional assays.
• Lead method development, qualification, transfer, and validation at internal labs and CDMOs while ensuring compliance with ICH Q2(R2), ICH Q6B, USP, and biologics-specific guidance.
• Ensure robust specification setting, comparability strategy, and control strategy alignment as programs advance.

• Direct release and stability testing for drug substance, drug product, intermediates, and raw materials under global GMP standards.
• Oversee QC laboratory capabilities, instrumentation strategy (HPLC/UPLC, CE, MS, ELISA, qPCR, cell-based platforms), and LIMS and data integrity systems.
• Ensure efficient sample management, chain of custody, and accurate phase-appropriate documentation.

• Lead QC investigations, OOS and OOT assessments, deviations, CAPAs, change controls, and stability commitments.
• Support regulatory submissions including INDs, IMPDs, and BLAs through authoring and review of analytical and QC sections.
• Represent QC in regulatory inspections and ensure readiness aligned with FDA, EMA, and ICH expectations for biologics and advanced modalities.

• Partner with CMC, Process Development, MSAT, Regulatory, and External Manufacturing teams to support analytical control strategies.
• Provide QC input for product lifecycle planning, risk assessments, fusion protein engineering updates, and comparability justifications.
• Manage QC activities at CDMOs and external labs including vendor qualification and ongoing performance monitoring.

• MS or PhD in Biochemistry, Molecular Biology, Immunology, Analytical Chemistry, or a related field.
• 10 to 15 years of QC experience in biologics or advanced modalities with at least 5 years in leadership roles.
• Expertise in analytical technologies for recombinant biologics and engineered fusion proteins.
• Experience supporting IND-enabling work, clinical material release, and method lifecycle management with CDMOs.
• Strong understanding of global GMP, ICH Q2(R2), Q5E, Q6B, and biologics regulatory frameworks.
• Proven capability in building QC teams, shaping lab infrastructure, and driving continuous improvement.
• Excellent leadership, communication, and cross-functional collaboration skills.