Karen Sum karen.sum@mail.mcgill.ca & | Pragmatic, hands-on, technically savvy (engineering background) Quality professional with broad experience from 10+ years of successful, on-time delivery of projects at leading biotech firms (Biogen, Genzyme and Millennium/Takeda). Managed CMOs, cGMPs, tech transfer, investigations, product recalls, process/system improvements and consent decree remediation. Solid understanding of biopharmaceutical development and manufacturing, aseptic processing, environmental monitoring and phase appropriate requirements for clinical and life cycle management of commercial products.

Karen Sum

Pragmatic, hands-on, technically savvy (engineering background) Quality professional with broad experience from 10+ years of successful, on-time...

Boston, Boston, United States

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Karen Sum’s Emails [email protected]

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Karen Sum’s Location Boston, Boston, United States

Karen Sum’s Expertise Pragmatic, hands-on, technically savvy (engineering background) Quality professional with broad experience from 10+ years of successful, on-time delivery of projects at leading biotech firms (Biogen, Genzyme and Millennium/Takeda). Managed CMOs, cGMPs, tech transfer, investigations, product recalls, process/system improvements and consent decree remediation. Solid understanding of biopharmaceutical development and manufacturing, aseptic processing, environmental monitoring and phase appropriate requirements for clinical and life cycle management of commercial products.

Karen Sum’s Current Industry Ultragenyx Pharmaceutical Inc.

Karen Sum’s Prior Industry
Biogen Idec | Complya Consulting Group | Millennium: The Takeda Oncology Company | EPIRUS Biopharmaceuticals | Ultragenyx Pharmaceutical Inc.

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Work Experience

Ultragenyx Pharmaceutical Inc.

Associate Director, Quality Assurance

Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

EPIRUS Biopharmaceuticals

Associate Director, Quality Assurance

Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Millennium: The Takeda Oncology Company

GMP Quality Manager, Global Investigational Quality (GIQ)

Sat Mar 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)

Complya Consulting Group

Quality Assurance Consultant, Consent Decree Remediation at Genzyme Allston Facility

Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)

Biogen Idec

Various Positions in Process Development and Quality

Wed Dec 01 1999 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

FAQ About Karen Sum

Karen Sum is located at
Boston, Boston, United States

Karen Sum is a
Pragmatic, hands-on, technically savvy (engineering background) Quality professional with broad experience from 10+ years of successful, on-time delivery of projects at leading biotech firms (Biogen, Genzyme and Millennium/Takeda). Managed CMOs, cGMPs, tech transfer, investigations, product recalls, process/system improvements and consent decree remediation. Solid understanding of biopharmaceutical development and manufacturing, aseptic processing, environmental monitoring and phase appropriate requirements for clinical and life cycle management of commercial products. Ultragenyx Pharmaceutical Inc.

Karen Sum currently works in the
Ultragenyx Pharmaceutical Inc.

Karen Sum specializes in
Pragmatic, hands-on, technically savvy (engineering background) Quality professional with broad experience from 10+ years of successful, on-time delivery of projects at leading biotech firms (Biogen, Genzyme and Millennium/Takeda). Managed CMOs, cGMPs, tech transfer, investigations, product recalls, process/system improvements and consent decree remediation. Solid understanding of biopharmaceutical development and manufacturing, aseptic processing, environmental monitoring and phase appropriate requirements for clinical and life cycle management of commercial products.

Karen Sum speaks the following languages:
No languages available.

Karen Sum has prior experience in the following industries:
Ultragenyx Pharmaceutical Inc. , EPIRUS Biopharmaceuticals , Millennium: The Takeda Oncology Company , Complya Consulting Group , Biogen Idec

Karen Sum has the following professional experience:
Ultragenyx Pharmaceutical Inc. , EPIRUS Biopharmaceuticals , Millennium: The Takeda Oncology Company , Complya Consulting Group , Biogen Idec .