Dan Herring Email & Phone Number

Waltham, Ma, Us

Global leadership and management of Thermo Fisher Scientific's Advanced Therapies CDMO Business Unit. This group includes three development and manufacturing plants located in California and Italy across three biotechnology modalities: mRNA production, Microbial Manufacturing Services (cGMP Plasmids), and Cell Therapy.- Accountability for the combined Advanced Therapies business' P+L including partnership on top line initiatives in the commercial organization.- Support and influence supporting functions such as Quality, Sales, Marketing, Finance, and Program and Account Management.- Directly responsible for Process and Analytical Development, Manufacturing Science and Technology (MSAT), Program Management, Supply Chain, and Manufacturing teams

Waltham, Ma, Us

Leadership of Thermo Fisher's multisite Cell Therapy CDMO business unit. - Accountability for the CTx business' P+L- Direct ownership of multisite operations and production- Lead Process and Analytical Development, Manufacturing Science and Technology (MSAT), Program Management, Supply Chain, and manufacturing teams

Basel, Ch

Head of Quality for Cell & Gene Technology Asset at Portsmouth, NH manufacturing site. Responsible for strategic and operational leadership of:- Quality Assurance and Lot Release- Cell and Gene Therapy Quality Control Labs and personnel- Validation Quality- Sterility Assurance- Quality Program and Customer Management

Boston, Massachusetts, Us

Head of Global Operations Compliance for Alexion Pharmaceuticals. Responsible for:- Global Health Authority compliance (FDA, HPRA, EMA, etc.) and inspection readiness- Supplier and CMO Quality: raw materials, components, CMO qualification- Supplier Quality Management System- Business Development Quality Due Diligence and Integration activities- Operations Quality Risk Management

Los Angeles, Ca, Us

Responsible for Company-wide cGMP quality compliance, assurance, control, improvement initiatives and programs across all product categories including third party manufacturing, internal and external warehouses, and corporate standards. Key accomplishments include the closure of two FDA governed voluntary product recalls, rapid investigation and resolution of a global supply related quality defect, and quality management of an international and domestic supplier network including China and Mexico.

Moorpark, Ca, Us

Principal consultant for Herring Consulting, helping biotechnology, pharmaceutical, and consumer goods firms achieve their quality, compliance and operational goals.

Tokyo, Jp, Jp

Continued leadership of the Quality Programs department at Baxalta through merger activities, see below.

Illinois, Us

Responsible for Quality Programs at newly spun-off Baxalta Inc.- Chief of Staff to Corporate Head of Quality- Global Quality Portfolio, Program and Project Management- Quality Knowledge/ Data Management, Analytics/Informatics and Reporting- Quality Strategic Planning, Quality Dashboard Reviews, and Global Compliance Excellence- Responsible for management of $252M global quality budgetAlso supporting FDA inspections and readiness at global manufacturing sites, continuous improvement efforts, and industry networking.

Deerfield, Illinois, Us

Site quality head at monoclonal antibody manufacturing plant (CHO cells) in Brooklyn Park, MN. Currently focused on building quality organization and implementing updates to local quality system. Member of senior leadership team responsible for setting site strategy and developing 5 year plan for site licensure.

Deerfield, Illinois, Us

Leading integration activities and Baxter quality system deployment at both a biosurgery device manufacturer and newly acquired recombinant manufacturing site in MN.

Deerfield, Illinois, Us

Project Manager responsible for driving a culture of compliance and quality across entire Baxter BioScience division. Responsible for division-wide inspection preparation plan and executing mock inspections at each site. Also owner of two quality systems at the division level. Managed two Global CAPA's to closure, managed the closure of FDA issued warning letter.Developed and deployed an IT solution for cascading regulatory citation information across sites for Baxter Healthcare Corporation.

Deerfield, Illinois, Us

Lead Internal Auditor responsible for maintaining cGMP compliance in a Biotechnology/Pharmaceutical recombinant CHO manufacturing plant. Also managed external agency inspections such as FDA, Mexico MoH, Brazil ANVISA, etc.

Deerfield, Illinois, Us

Responsible for Compliance metrics, Management Reviews, and managing compliance related systems such as the internal audit program and FDA commitments.

Deerfield, Illinois, Us

Expert in purification techniques for human blood plasma based drug manufacturing.

Camarillo, Ca, Us

Studied various Biotechnology techniques, proposed new drug concept for Glaucoma, and presented a theoretical new therapy for heart disease using induced pluripotent stem cells and aptamer technology.

B.A., Biology

M.S., Biotechnology