Maggie Chen

Maggie Chen Email and Phone Number

Sr. Vice President, Site Head @ KBI Biopharma
1101 Hamlin Rd, Durham, NC 27704
Maggie Chen's Location
United States, United States
Maggie Chen's Contact Details

Maggie Chen personal email

n/a
About Maggie Chen

Proven track record leader in Manufacturing, MS&T, Quality and Engineering with 20+ years of FDA regulated industry experience (Pharmaceutical, CAR-T, Gene Therapy, Medical Device, and Consumer Health). Successfully build and lead high performing team (2x improvement within 12 months). Solid validation expertise to manage complex validation programs. Excels at process redesign and improvement. Passionate and results oriented. International Experiences (US, Canada & China).SKILLS & EXPERTISE• FDA inspection; Quality System remediation and implementation• Operation & Lean Transformation; Project Management• Qualification, Validation and CPV expertise

Maggie Chen's Current Company Details
KBI Biopharma

Kbi Biopharma

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Sr. Vice President, Site Head
1101 Hamlin Rd, Durham, NC 27704
Website:
kbibiopharma.com
Maggie Chen Work Experience Details
  • Kbi Biopharma
    Senior Vice President, Site Head
    Kbi Biopharma Nov 2023 - Present
    Durham, North Carolina, Us
    -Oversee commercial, high run rate, biologic manufacturing Operation -Manage the site operation and P&L-Manage all functional aspects of Production, Facility &Engineering, MST, Supply Chain, EHS & Administration-Manage near term and long range capacity planning -Manage client relationship and maintain customer satisfaction level
    View
  • Agc Biologics
    Sr. Director, Manufacturing (Cgt ), Interim Eng Head For Cgt & Biologics
    Agc Biologics Sep 2021 - Oct 2023
    Bothell, Wa, Us
    -Oversee Viral Vector manufacturing and Cell Therapy manufacturing-Oversee Manufacturing Science and Technology function-Lead site Operational Readiness for site startup-Establish Cell & Gene manufacturing strategy for LGT site-Setup core mfg capability, staffing model, Capital investment aligns with rapidly growing market demand-Initiate Cell Therapy and build capacity-Support client interactions
    View
  • Novartis Gene Therapies
    Director, Global Head Of Validation; Head Of Engineering, Longmont Site
    Novartis Gene Therapies Sep 2019 - Sep 2021
    Basel, Baselstadt, Ch
    -Lead/Manage site Engineering functions, set network strategies-Drive Gene Therapy site start up (accomplished in 9 months)-Set GTx global validation strategy-Establish global validation program (C&Q, QC, CSV, CV, APV etc.)-Manage and Optimize validation executions cross all GTx sites
    View
  • Novartis Gene Therapies
    Interim Assignment - Mst
    Novartis Gene Therapies 2018 - Sep 2019
    Basel, Baselstadt, Ch
    -Support MST Projects (APV, shipping studies)-Generate procedure and execution form for Container Closure Integrity Test Program-Tech lead for Media campaign project-Support new manufacturing Module start up and process changes
    View
  • Novartis
    Associate Director, Ms&T
    Novartis 2016 - 2019
    -Manage Validation Team and contractors-Lead Site Process Validation Program, Cleaning Validation Program, Packaging Validation Program and Continued Process Validation Program-Own/Manage site VMP and to ensure compliance and on time execution-Support tech transfer projects and new product lunch-Lead Cluster validation network for Americas sites to ensure Novartis policies alignment cross sites-Support FDA inspection as strategy lead
  • Novartis
    Sr. Product Steward, Ms&T
    Novartis 2014 - 2016
  • Novartis
    Sr Quality Engineer Lead
    Novartis Jan 2011 - 2014
  • Spectranetics (Now Philips)
    Quality Computer/Software Validation Lead
    Spectranetics (Now Philips) 2009 - 2011
  • Johnson & Johnson
    Manufacturing Engineering Project Manager & Validation Specialist
    Johnson & Johnson 2002 - 2009
    New Brunswick, Nj, Us
    View
  • Johnson & Johnson
    Project Manager
    Johnson & Johnson 1998 - 2001
    New Brunswick, Nj, Us
    View

Maggie Chen Skills

Capa Change Control Validation Fda Gmp Pharmaceutical Industry Quality System Gxp Quality Assurance 21 Cfr Part 11 Technology Transfer V&v Process Improvement Regulatory Affairs Medical Devices Iso 13485 Cross Functional Team Leadership Sop Quality Auditing

Maggie Chen Education Details

  • University Of Colorado Denver
    University Of Colorado Denver
    Executive Mba
  • Xi'An Jiaotong University
    Xi'An Jiaotong University
    Industrial Engineering / Mechanical Engineering

Frequently Asked Questions about Maggie Chen

What company does Maggie Chen work for?

Maggie Chen works for Kbi Biopharma

What is Maggie Chen's role at the current company?

Maggie Chen's current role is Sr. Vice President, Site Head.

What is Maggie Chen's email address?

Maggie Chen's email address is ma****@****tis.com

What schools did Maggie Chen attend?

Maggie Chen attended University Of Colorado Denver, Xi'an Jiaotong University.

What skills is Maggie Chen known for?

Maggie Chen has skills like Capa, Change Control, Validation, Fda, Gmp, Pharmaceutical Industry, Quality System, Gxp, Quality Assurance, 21 Cfr Part 11, Technology Transfer, V&v.

Who are Maggie Chen's colleagues?

Maggie Chen's colleagues are William Yoder, Justin Watkins, Ph.d., Kimberly Heid, Krista Wilson, Bradley Hollers, Kristopher Frances, Eloise Bailey.

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