Vivid Resourcing
Director, Quality Control (QC)
Location:
Cambridge, MA (Hybrid)
Overview 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.
Key Responsibilities
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.
Analytical & Method Lifecycle Ownership
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.
QC Operations & Laboratory Management
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.
Quality Systems & Regulatory Readiness
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.
Cross-Functional Collaboration
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.
Qualifications
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.
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Location:
Cambridge, MA (Hybrid)
Overview 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.
Key Responsibilities
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.
Analytical & Method Lifecycle Ownership
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.
QC Operations & Laboratory Management
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.
Quality Systems & Regulatory Readiness
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.
Cross-Functional Collaboration
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.
Qualifications
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.
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