Steven Lang Email and Phone Number

Leading groups in cell culture Process Development, Production, and Analytical R&D. We are developing innovative cell culture processes and generating analytical data to deliver scalable and cost-effective delicious cultured meat.

Interface with clients, operational staff, business development, and program management to deliver contract research in antibody discovery, molecular biology, USP, DSP, analytical characterization, formulation and cell line development.Build strategic growth plans to maintain a robust project pipeline in collaboration with sales and marketing.Engage with virtual biotechs and large pharmaceutical companies alike to build productive relationships simultaneously meeting scientific, regulatory, and business needs. Lead diverse teams with operations in California and India. Accountable to CEO, board of directors and parent company, Aragen Life Sciences.

Managed groups responsible for expression assessment, research reagent generation, cell line development, cell culture automation and imaging, technology development, and CHO process development. As CMC lead delivered an innovative bispecific antibody into clinical trials.Developed and led projects to digitize scientific data management processes across the global Roche Technical Development network to drive innovation, efficiency, transparency and compliance. Conducted change management, coaching, due diligence, innovation and technology development projects.

Supported large molecule drug discovery and early development leading three functional groups providing developability, manufacturing cell lines and stability screening.Improved technology, process and governance processes that reduced cell line development timelines by >40% and increased throughput fivefold. Innovated processes in Analytical Discovery group to increase throughput 7x in 3 years. Collaborated with Business Development on due diligences of external assets and companies.

Biologics Research - Cell Line Development and Mass SpectrometryI led two groups of scientists who are responsible for the development of commercial and reagent cell lines (mammalian and microbial), genetic characterization, process and media optimization and mass spectrometry characterization of proteins (from peptides to antibodies). I am responsible for planning and tracking projects, identifying and solving problems, implementing innovation and change, managing costs and risks, coaching team leaders, documenting results for regulatory submissions and responding to questions from health authorities. We interface between discovery and development by understanding constraints and processes of both organizations, assuring seamless transfers of new molecular entities. I have implemented technologies to improve cell line development efficiencies >10-fold. This enables an early development strategy with parallel processing and front-loading that improves clinical success rates.

B.I.O. Pharmaceutical Development and Marketed Product Support - Gene Expression and Cell TherapiesI was accountable for the operational management of cell line development, early process optimization and genetic characterization projects. I redesigned the genetic characterization process resulting in a 68% reduction in resources and time needed to complete a project to satisfy ICH Q5B guidelines. I managed direct reports in addition to multiple cross-functional project teams. We focused on developing technologies to enhance cell line selection and manufacturing processes emphasizing process automation of fermentation models (fed-batch and perfusion) and high-throughput analytical techniques.