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