SlideShare ist ein Scribd-Unternehmen logo
1 von 2
Katie L. Moberg
116 W. 1st
Ave. Conshohocken, PA
267-337-2091 (C), katielmoberg@gmail.com
Employment Experience
Janssen Pharmaceuticals, a Johnson & Johnson Company
Clinical Supply Chain Manager August 2016-Present
 Developing E2E planning configuration
 Define net requirements for DP and API for each compound
 Align Master Production Schedules and Inventory plans and manage allocation of batches
 Utilize software (OMP and SAP) to effectively balance demand and supply
 Resolve any supply related issues to avoid supply constraints
 Collaborate with business partners to drive flexibility and reliability in supply
McNeil Consumer Healthcare, a Johnson & Johnson Company
MES / Master Data Specialist III July 2013-August 2016
 Collaborate strongly with Operations, Automation, Quality, and Engineering to prepare Master Batch Records for
all batches (Chem Weigh, Mixing and Packaging).
 Participate in and act as SME in all types of audits & Inspections
 Successfully presented to FDA Auditors in certification audit
 Collaborate with Lancaster and Las Piedras to standardize and simplify electronic MBRs
 Lead Library Element creation aspect of the Simplification Project which created standard “building blocks” for
MBR Designers across J&J to utilize during MBR creation
 Serve as Site Master Data Lead – Coordinate the creation / maintenance of all Master Data for the Fort
Washington (FW) plant. Ensure that all elements of Master Data are aligned and accurate
 Provide day-to-day support for the site’s manufacturing execution systemas subject matter expert.
 Create Operator Training for Master Batch Records and present to all users
 Develop the Paper Packaging Master Batch Record(s) and templates from scratch
 Member of the Talent Development Credo Team
o Co-Lead for the “Taking Charge of Your Career” session
Merck & Co.
Process Engineer (Global Pharmaceutical Commercialization) June 2011-July 2013
 Manage multiple programs simultaneously with both Early Development as well as Commercialization
formulators to plan and execute various programs and batches for Clinical Trials
 Program indications: Hepatitis C, Heart disease / High Blood Pressure, Insomnia, HIV, Pediatric Cancer
 Hold Batch Activity Grid meetings with all relevant groups (Analytical, Global Supply Chain Planner,
Formulator(s), Manufacturing Scientists, etc.) to ensure all expectations and deadlines are met for each program
 Execute batch planning and close-out activities in Manufacturing Resource Planning application (ERPCSO
POMS), as well as creating recipes and batch records.
 Achieved a batch record Right First Time Rate of >98.5% (0 errors in the entire Batch Packet)
 Forecast with Procurement – Ensure all raw materials needed for each batch are ordered and released in time for
manufacturing
 Preparation of GMP documentation (including Batch Records, SOPs, Specification Files and Deviation
Investigations)
 Batch Record Template Owner - Create and make any necessary changes to Batch Record templates.
 Actively participate in various project teams, including: Right First Time team, Batch Template Harmonization
team
 Implemented new technology (anti-bearding nozzles) for film coating system including research and organization
of purchase for use - achieved 30% time reduction per batch.
Manufacturing Scientist (GlobalPharmaceutical Commercialization) Jan2009 – June 2011
 Communicate with development scientists and operations engineers to identify proposed product processes.
 Negotiate the use of alternate materials and/or manufacturing equipment when necessary.
 Serve as primary owner of on-floor manufacturing activities which include: Blending, Roller Compaction,
Compressing, Hot Melt Extrusion, Film Coating, etc.
 Execute batch planning and close-out activities in Manufacturing Resource Planning application, as well as
creating recipes and batch records.
 Preparation of GMP documentation (including SOPs and deviation investigations)
 Participation in the ordering and qualification of new process equipment.
 Serve as equipment owner of all Pan Coaters, balances, weight sets, hardness testers, thickness gauges,
disintegration baths, and friabilators.
 Complete any Out of Tolerance investigations associated with equipment.
 Create and make any necessary changes to Batch Record templates.
Product Coordination / Development Engineer (GPC) Oct 2007 –Dec 2008
 Coordinate the manufacture of both sterile and non-sterile pharmaceutical and/or biological liquid products for
clinical trials, in collaboration with process development, analytical sciences, quality, clinical supply, and other
key stakeholders
 Collaborate with product development staff in the process design and equipment selection for batch manufacture
 Guide pilot plant technicians in the formulation, filtration, filling, lyophilization, terminal sterilization, and
inspection of clinical products
 Participate in non-sterile and aseptic manufacturing operations
 Develop manufacturing protocols and preparing final batch records for release
 Coordinate with analytical scientists, quality, and clinical supply to ensure that all product release activities meet
timing and documentation requirements
 Investigate and report atypical process events
 Took an active role in process and facility optimization to support Commercialization initiatives for operational
excellence
Dispenser / Chemical Engineer (GPC) Oct 2004 – Oct 2007
 Plan, Schedule and Dispense all raw materials in accordance with project timelines.
 Communicate directly with formulators to assist in placing requests, changing batches, shipment of materials, etc.
 Heavily involved in the planning and implementation of Chem Stock Manager 2.0 (Material Ordering System)
 Heavily involved in the implementation of ERPCSO / POMS in Chem Stock
 Complete an annual cycle count of inventory; evaluate any variances/issues.
 Collaborate with GMP Compliance with release documentation for excipients
Education
The Pennsylvania State University, May 2004
Bachelor of Science in Bio Behavioral Health
 3.45 GPA
 Dean's List Academic Achievement
University of Salamanca, 1/03-4/03
Study Abroad Program (Minor: Spanish)
Studied Spanish language, art, and culture; proficient speaking skills
Certifications
 Six Sigma Yellow Belt Certified

Weitere ähnliche Inhalte

Was ist angesagt? (20)

CV - SBeer 26-08-16
CV - SBeer 26-08-16CV - SBeer 26-08-16
CV - SBeer 26-08-16
 
Lynn Kostas Resume 2016
Lynn Kostas Resume 2016Lynn Kostas Resume 2016
Lynn Kostas Resume 2016
 
Kent Waldron Cur.V_10-17
Kent Waldron Cur.V_10-17Kent Waldron Cur.V_10-17
Kent Waldron Cur.V_10-17
 
Patricia brady resume 22 dec2016
Patricia brady resume 22 dec2016Patricia brady resume 22 dec2016
Patricia brady resume 22 dec2016
 
Cesar Soto Sep 2016
Cesar Soto Sep 2016Cesar Soto Sep 2016
Cesar Soto Sep 2016
 
Walter King Resume 2015
Walter King Resume 2015Walter King Resume 2015
Walter King Resume 2015
 
Ashwini_Ghangale_new
Ashwini_Ghangale_newAshwini_Ghangale_new
Ashwini_Ghangale_new
 
Resume 2018
Resume 2018Resume 2018
Resume 2018
 
Tammy Flory 2017
Tammy Flory 2017Tammy Flory 2017
Tammy Flory 2017
 
CV_2015_english
CV_2015_englishCV_2015_english
CV_2015_english
 
CV-LAJ
CV-LAJCV-LAJ
CV-LAJ
 
GIKANDI, William Resume
GIKANDI, William ResumeGIKANDI, William Resume
GIKANDI, William Resume
 
Resume - B. Ervin Final
Resume - B. Ervin FinalResume - B. Ervin Final
Resume - B. Ervin Final
 
Kimberly -resume
Kimberly -resumeKimberly -resume
Kimberly -resume
 
Resume1
Resume1Resume1
Resume1
 
Brendan Naughton CV
Brendan Naughton CVBrendan Naughton CV
Brendan Naughton CV
 
Cesar Soto MAR. 2016
Cesar Soto MAR. 2016Cesar Soto MAR. 2016
Cesar Soto MAR. 2016
 
CV M Hervella
CV M HervellaCV M Hervella
CV M Hervella
 
Resume Kevin_Koski_August_2016
Resume Kevin_Koski_August_2016Resume Kevin_Koski_August_2016
Resume Kevin_Koski_August_2016
 
Curriculum Vitae
Curriculum VitaeCurriculum Vitae
Curriculum Vitae
 

Andere mochten auch

Andere mochten auch (9)

resume
resumeresume
resume
 
Adam J. Crank Resume June 2013
Adam J. Crank Resume June 2013Adam J. Crank Resume June 2013
Adam J. Crank Resume June 2013
 
RESUME
RESUMERESUME
RESUME
 
ResumeRev04302016
ResumeRev04302016ResumeRev04302016
ResumeRev04302016
 
Genesis Montano Resume Ver3
Genesis Montano Resume Ver3Genesis Montano Resume Ver3
Genesis Montano Resume Ver3
 
Sheri Wilt-Resume
Sheri Wilt-ResumeSheri Wilt-Resume
Sheri Wilt-Resume
 
Resume - Joyce Ann Lotkowski
Resume - Joyce Ann LotkowskiResume - Joyce Ann Lotkowski
Resume - Joyce Ann Lotkowski
 
Acciardi Resume 2016
Acciardi Resume 2016Acciardi Resume 2016
Acciardi Resume 2016
 
Joseph Consiglio Resume 1
Joseph Consiglio Resume 1Joseph Consiglio Resume 1
Joseph Consiglio Resume 1
 

Ähnlich wie RESUME Katie Moberg (20)

Hanife Akin -updated
Hanife Akin -updatedHanife Akin -updated
Hanife Akin -updated
 
resume FM1.1.17
resume FM1.1.17resume FM1.1.17
resume FM1.1.17
 
El-Komy CV
El-Komy CVEl-Komy CV
El-Komy CV
 
El-Komy CV
El-Komy CVEl-Komy CV
El-Komy CV
 
Jacqueline Lebron Figuera Resume
Jacqueline Lebron Figuera ResumeJacqueline Lebron Figuera Resume
Jacqueline Lebron Figuera Resume
 
Resume brian shipano
Resume brian shipanoResume brian shipano
Resume brian shipano
 
resume Brian Shipano
resume Brian Shipanoresume Brian Shipano
resume Brian Shipano
 
Resume 2016
Resume 2016Resume 2016
Resume 2016
 
LinkedIn Resume
LinkedIn ResumeLinkedIn Resume
LinkedIn Resume
 
Job Description
Job DescriptionJob Description
Job Description
 
RESUME
RESUMERESUME
RESUME
 
RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016RONALD PREIBIS Resume Fall 2016
RONALD PREIBIS Resume Fall 2016
 
ResumeMay2015_GWilliams
ResumeMay2015_GWilliamsResumeMay2015_GWilliams
ResumeMay2015_GWilliams
 
Pedro Perez
Pedro PerezPedro Perez
Pedro Perez
 
resume Diana Lourdes Santiago
resume Diana Lourdes Santiagoresume Diana Lourdes Santiago
resume Diana Lourdes Santiago
 
Brian D. Wilson resume 2015 share
Brian D. Wilson  resume 2015 shareBrian D. Wilson  resume 2015 share
Brian D. Wilson resume 2015 share
 
DonnaJenkinsresume
DonnaJenkinsresumeDonnaJenkinsresume
DonnaJenkinsresume
 
Stephen Keokhanthachone Resume Jan. 2017
Stephen Keokhanthachone Resume Jan. 2017Stephen Keokhanthachone Resume Jan. 2017
Stephen Keokhanthachone Resume Jan. 2017
 
Lam Chi Chung CV new HK
Lam Chi Chung CV new HKLam Chi Chung CV new HK
Lam Chi Chung CV new HK
 
JANELLE HEPPES RESUME
JANELLE HEPPES RESUMEJANELLE HEPPES RESUME
JANELLE HEPPES RESUME
 

RESUME Katie Moberg

  • 1. Katie L. Moberg 116 W. 1st Ave. Conshohocken, PA 267-337-2091 (C), katielmoberg@gmail.com Employment Experience Janssen Pharmaceuticals, a Johnson & Johnson Company Clinical Supply Chain Manager August 2016-Present  Developing E2E planning configuration  Define net requirements for DP and API for each compound  Align Master Production Schedules and Inventory plans and manage allocation of batches  Utilize software (OMP and SAP) to effectively balance demand and supply  Resolve any supply related issues to avoid supply constraints  Collaborate with business partners to drive flexibility and reliability in supply McNeil Consumer Healthcare, a Johnson & Johnson Company MES / Master Data Specialist III July 2013-August 2016  Collaborate strongly with Operations, Automation, Quality, and Engineering to prepare Master Batch Records for all batches (Chem Weigh, Mixing and Packaging).  Participate in and act as SME in all types of audits & Inspections  Successfully presented to FDA Auditors in certification audit  Collaborate with Lancaster and Las Piedras to standardize and simplify electronic MBRs  Lead Library Element creation aspect of the Simplification Project which created standard “building blocks” for MBR Designers across J&J to utilize during MBR creation  Serve as Site Master Data Lead – Coordinate the creation / maintenance of all Master Data for the Fort Washington (FW) plant. Ensure that all elements of Master Data are aligned and accurate  Provide day-to-day support for the site’s manufacturing execution systemas subject matter expert.  Create Operator Training for Master Batch Records and present to all users  Develop the Paper Packaging Master Batch Record(s) and templates from scratch  Member of the Talent Development Credo Team o Co-Lead for the “Taking Charge of Your Career” session Merck & Co. Process Engineer (Global Pharmaceutical Commercialization) June 2011-July 2013  Manage multiple programs simultaneously with both Early Development as well as Commercialization formulators to plan and execute various programs and batches for Clinical Trials  Program indications: Hepatitis C, Heart disease / High Blood Pressure, Insomnia, HIV, Pediatric Cancer  Hold Batch Activity Grid meetings with all relevant groups (Analytical, Global Supply Chain Planner, Formulator(s), Manufacturing Scientists, etc.) to ensure all expectations and deadlines are met for each program  Execute batch planning and close-out activities in Manufacturing Resource Planning application (ERPCSO POMS), as well as creating recipes and batch records.  Achieved a batch record Right First Time Rate of >98.5% (0 errors in the entire Batch Packet)  Forecast with Procurement – Ensure all raw materials needed for each batch are ordered and released in time for manufacturing  Preparation of GMP documentation (including Batch Records, SOPs, Specification Files and Deviation Investigations)  Batch Record Template Owner - Create and make any necessary changes to Batch Record templates.  Actively participate in various project teams, including: Right First Time team, Batch Template Harmonization team  Implemented new technology (anti-bearding nozzles) for film coating system including research and organization of purchase for use - achieved 30% time reduction per batch.
  • 2. Manufacturing Scientist (GlobalPharmaceutical Commercialization) Jan2009 – June 2011  Communicate with development scientists and operations engineers to identify proposed product processes.  Negotiate the use of alternate materials and/or manufacturing equipment when necessary.  Serve as primary owner of on-floor manufacturing activities which include: Blending, Roller Compaction, Compressing, Hot Melt Extrusion, Film Coating, etc.  Execute batch planning and close-out activities in Manufacturing Resource Planning application, as well as creating recipes and batch records.  Preparation of GMP documentation (including SOPs and deviation investigations)  Participation in the ordering and qualification of new process equipment.  Serve as equipment owner of all Pan Coaters, balances, weight sets, hardness testers, thickness gauges, disintegration baths, and friabilators.  Complete any Out of Tolerance investigations associated with equipment.  Create and make any necessary changes to Batch Record templates. Product Coordination / Development Engineer (GPC) Oct 2007 –Dec 2008  Coordinate the manufacture of both sterile and non-sterile pharmaceutical and/or biological liquid products for clinical trials, in collaboration with process development, analytical sciences, quality, clinical supply, and other key stakeholders  Collaborate with product development staff in the process design and equipment selection for batch manufacture  Guide pilot plant technicians in the formulation, filtration, filling, lyophilization, terminal sterilization, and inspection of clinical products  Participate in non-sterile and aseptic manufacturing operations  Develop manufacturing protocols and preparing final batch records for release  Coordinate with analytical scientists, quality, and clinical supply to ensure that all product release activities meet timing and documentation requirements  Investigate and report atypical process events  Took an active role in process and facility optimization to support Commercialization initiatives for operational excellence Dispenser / Chemical Engineer (GPC) Oct 2004 – Oct 2007  Plan, Schedule and Dispense all raw materials in accordance with project timelines.  Communicate directly with formulators to assist in placing requests, changing batches, shipment of materials, etc.  Heavily involved in the planning and implementation of Chem Stock Manager 2.0 (Material Ordering System)  Heavily involved in the implementation of ERPCSO / POMS in Chem Stock  Complete an annual cycle count of inventory; evaluate any variances/issues.  Collaborate with GMP Compliance with release documentation for excipients Education The Pennsylvania State University, May 2004 Bachelor of Science in Bio Behavioral Health  3.45 GPA  Dean's List Academic Achievement University of Salamanca, 1/03-4/03 Study Abroad Program (Minor: Spanish) Studied Spanish language, art, and culture; proficient speaking skills Certifications  Six Sigma Yellow Belt Certified