Brian Krisak

Director, Cmc Project Management @Viridian Therapeutics, Inc.

Nashua, NH, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2024 — Present

Director, Cmc Project Management @Viridian Therapeutics, Inc.

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Waltham, MA, US

SKILLS

Pharmaceutical IndustrySopFdaComputer System ValidationCapaGmpBiopharmaceuticalsChange ControlTechnology TransferCorrective and Preventive Action (Capa)Standard Operating Procedure (Sop)TrackwiseValidationGlp21 Cfr Part 11GxpAseptic ProcessingU.s. Food and Drug Administration (Fda)ManufacturingQuality AssuranceQuality SystemV&VBiotechnology

ABOUT BRIAN KRISAK

TAKEDA (formerly SHIRE), Lexington, MAAssociate Director – Global Device Program Manager (Jun 2019 – May 2022)• Lead & manage Device & Combination Product(s) through Product Lifecycle stage gate process (preclinical to commercial).• Lead & Facilitate operational Device planning activities, including the development & deployment of continuous improvement Device Center of excellence business initiatives, process & best practice.• Prepare and manage multiple Device related Program Budgets.Takeda (formerly SHIRE), Lexington, MAProgram Manager–Product Life Cycle Management (Sept 2017- Present)Lead & manage respective Product team(s) through Product Life Cycle stage gate process (preclinical to commercial).Reports program status/timelines into governance committee. Responsible for program budget & overseeing capital expenditureLead Program meetings, collaborate & communicate effectively SARTORIUS, Boston, MA Integrated Solutions Manager – Sales (Jun 2016 – Sept 2017)Lead & develops IS projects-Analyze incoming inquiries & formal bid invitations from Customers to create cost effective solution, meeting the projects financial & schedule requirementsLONZA, Portsmouth, NHProgram Manager (Jul 2015 – Jun 2016)Lead program execution after deal closure. Develop project plans & lead program through stage gate life cycleSHIRE, Cambridge, MASr. Operations Project Manager (Aug 2011-Jul 2015) Operations Project Manager (20••••11)Project lead for site wide Regulatory Commitments, interface w/ Sr. Leadership/support departments.WYETH BIOTECH, Andover, MASr. Supervisor Manufacturing / Compliance Coordinator (20••••08)EVM / AMF Planner (20••••07)Suite Coordinator II (Sr. Supervisor 20••••06) Cell CultureTechnical Trainer (20••••02) Cell Culture Process Technician - 2001) Cell Culture STATE OF NEW JERSEY Dept. of Community Affairs, North Brunswick, NJProgram Coordinator (1993 -

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Brian Krisak — Director, Cmc Project Management at Viridian Therapeutics, Inc. in Nashua, NH, US | Unifers