Jay Millwater

Director, Biologics Drug Product Development & Manufacturing

Role: Director, Biologics Drug Product Development & Manufacturing at Zenas BioPharma
Location: San Diego, CA, US
LinkedIn followers: 500 followers

About Jay Millwater

Accomplished Manufacturing Manager with extensive experience in all phases of Operations and Supply Chain Management for Clinical, Commercial, and Contract Manufacturing in the Pharmaceutical/Biotech industry. Combines proven ethical leadership skills and excellent written and verbal communication skills with a vast knowledge of current Federal regulations to deliver results through a highly skilled workforce. Consistently meets and exceeds client expectations by adjusting resources to create a nimble production schedule for customers’ ever-changing needs. Managed all phases of operations in Biotech/pharmaceutical industry including upstream and downstream support activities, packing and labeling, and sterile Fill finish.

Experience

Director, Biologics Drug Product Development & Manufacturing
Zenas BioPharma
Sep 2022 — Present · US

Education

Southern Wesleyan University
B.S., Management
2010

Skills

Software Documentation
Regulatory Affairs
Pharmaceutical Industry
Sop
Fda
Gmp
Biopharmaceuticals
Human Resources
21 Cfr Part 11
Glp
Computer System Validation
Biotechnology
Validation
Quality Assurance
Aseptic Processing
Regulatory Submissions
Cleaning Validation
Medical Devices
Capa
U.s. Food and Drug Administration (Fda)
Manufacturing
Lims
Change Control
Technology Transfer
Business Development
Quality System
V&V

Contact information

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Work email
j••••••••@zenasbio.com
Personal email
•••••@•••••.com
Direct dial
+18•••••••78

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Current company

Zenas BioPharma

Biotechnology Research · 198 employees · Waltham, Massachusetts, United States

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in multiple sclerosis. Zenas’ earlier stage programs include ZB021, a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor.

zenasbio.com

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