Michael Maria Email & Phone Number

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States

Drove Quality Assurance governance over a complex clinical program involving mobile phlebotomy, biobanking, and multi-omics processing by third party vendors. Led quality-related sunsetting tasks associated with program completion, including summary, quality metrics and reference documentation, sample destruction requests, and third party close out audit.

Led internal and commercial consulting projects leveraging patient generated health and multi-omics data to glean biological insights at the individual and population level for the patient, clients, and internal product development. Facilitated molecular translation, data and knowledge engineering, and data analytics team verticals.

Managed projects end to end in a commercial consulting environment, from initial statement of work definition through project close out. Projects leveraged proprietary analysis of gene expression data and biological process modeling to drive insights such as disease vs normal, treatment response vs non-response, target ID, individual patient analyses and stratification, and biomarker development for therapeutic products in pre-clinical, clinical, and post-approval stages.

Cambridge, Ma

Managed QC lot release, incoming raw materials, and cell culture functional groups in a GMP/ISO certified cell therapy production operation for clinically approved and investigational cell therapy products including cartilage, keratinocyte, skeletal myoblast, and dendritic/tumor fusion products. Led a team of eight across two sites and oversaw assay transfer, management, and scheduling. Completed deviation and CAPA implementation, data metrics/reporting, and billing. Participated in FDA, ISO, corporate, and internal audits.

Master Of Engineering - Meng, Biotechnology Engineering

Bachelor Of Science - Bs, Biology