Vivid Resourcing · 1 month ago
Director of Quality Control
Cambridge, MA
Full-time
Onsite
Director/Executive
10+ years expVivid Resourcing is an innovative biotechnology company developing next-generation biologics and engineered fusion protein therapeutics focused on immune and autoimmune-driven diseases. The Director of Quality Control will build and scale the QC function, ensuring analytical excellence and driving phase-appropriate GMP compliance across a growing modality portfolio.
EmploymentRecruitingStaffing Agency
Hiring Manager
Joel Isaac
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
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
Qualification
Required
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
Company
Vivid Resourcing
Vivid Resourcing is a consultancy that provides recruitment, staffing, job search and employment services for various sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase