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Current company Northbridge Life Sciences, Llc
Pharmaceutical Manufacturing · 1 employees · Founded 2025
At Northbridge Life Sciences, we provide expert consulting services to the pharmaceutical and biotechnology industries, with a focus on Manufacturing Sciences & Technology (MS & T), technical operations, and quality-driven process development. Leveraging over two decades of hands-on experience in GMP environments—from early-stage development to commercial manufacturing—we help our clients navigate complex challenges across the product lifecycle. Our core services include: Tech Transfer & CDMO Management: End-to-end support for tech transfers between sponsors and CDMOs, including SOW development, knowledge transfer, and production readiness. We ensure seamless transitions that protect supply chain continuity. Process Optimization & Scale-Up: Data-driven optimization of upstream and downstream processes to improve yield, reduce variability, and support scale-up. Our approach integrates QbD principles and advanced statistical modeling (DoE, multivariate analysis). Quality & Regulatory Support: Guidance on quality risk management, root cause analysis, and CAPA development. We partner closely with client QA teams to prepare for audits, resolve compliance issues, and strengthen quality systems. Cell & Gene Therapy Expertise: Specialized support for cell therapy (CAR T), including process development, and clinical readiness. MS & T Strategy Development: Build or enhance MS & T capabilities within your organization. We offer interim leadership, department structuring, lab design, and training of technical staff. Whether you\'re a start-up preparing for IND submission or an established organization optimizing a legacy product, Northbridge Life Sciences delivers the technical insight and operational know-how to accelerate progress and ensure product quality.
northbridgelifesciences.com