KARRIE CHRISTMAN

487 Oceanview Drive, Vista CA 92084│C: 760-277-7812│E:

SUMMARY

An innovative, scientific professional with a broad knowledge base in the biopharmaceutical industry. A proven record of success at building and developing teams with different levels of technical and professional experience to successfully achieve company goals.Focused on driving for results through accountability, collaborating with clients, customers, and co-workers at all levels of the organization, and leveraging substantial hands on experience.

ACCOMPLISHMENTS

  • Built Quality Control (QC) department for Gilead Biologics Manufacturing Facility from ground up
  • Hired 32 employees from 2011-2016 to support QC operations
  • Established and maintained partnerships with contract testing labs to test GMP (Good Manufacture Practices) samples
  • Managed development and implementation of Laboratory Information Management System (LIMS)and other laboratory systems
  • Developed processes and procedures to hire, train, and retain talent
  • Served as primary contact during different types of Regulatory Audits throughout career
  • Saved $1.3M in 2012 by expanding in-house testing capabilities for samples that were high volume and had quick turn-around-times (TAT)
  • Experienced with products made by CHO for Phase I – Commercial
  • Developed, implemented, and maintained GMP compliance programs for QC Department
  • Member of Global teams that were established to create efficiency and drive change throughout company on Quality Systems

PROFESSIONAL EXPERIENCE

Gilead Sciences, Inc.

4049 Avenida de la Plata, Oceanside, CA 92056 September 2011-Present

Senior Manager, Quality Control (January 2015-Present)

  • Successfully lead a team of 26 Quality Control professionals to support the GMP Biologics Manufacturing facility
  • Responsible for in-process and bulk release testing, quality systems, method validations and verifications, and sample management
  • Manage In-Source employees from Eurofins Lancaster Laboratories Inc.
  • Strategically position employees to achieve aggressive company goals by improving efficiencies and streamlining processes while adhering to established regulations
  • ProgressGilead Biologics Facility from a Clinical to Commercial Facility for Gilead’s first Biologics product
  • Responsible for validation and verification of methods for in-process and release testing for Gilead Biologics products
  • Trend data and monitor methods to make necessary improvements
  • Change Owner for Analytical OperationsNew Product Inductions (NPI’s), which includes activities such as: Master Cell Bank used in the Manufacturing of the new product, analytical method validation, verification and transfer, approval of new test methods and creation of Sampling Plan and Specification that governs testing
  • Lead $1.2M Lab Expansion project, which resulted in a 50% increase of testing capacity and capabilities
  • Direct Installation Qualification, Operational Qualification, and Performance Qualification(IQ/OQ/PQ’s) for instruments and equipment, vendor relationships, deviations, Corrective and Preventative Actions, Change Managements, Out of Specifications (OOS), Out of Trends (OOT) and Over Action Limits
  • Serve on Global teams that focus on business alignment, improvements to processes and procedures, and increasing industry knowledge
  • QC Network Team
  • OOS/OOT Team
  • Data Integrity Team
  • Laboratory Information Systems Team
  • Continuously develop career by being mentored by Senior Leaders, mentoring others, attending trainings and conferences, presenting on scientific topics, and representing Biologics for Global teams

Manager, Quality Control (September 2011-January 2015)

Managed all aspects of Quality Control including product testing, method validation, method transfer, specifications, raw materials, process validation, environmental monitoring, trending, laboratory systems, and quality systems

  • First person hired in Quality Control Department; specifically written into Gilead’s Legal Purchase Agreement of Genentech’s Clinical Facility
  • Managed $2M budget
  • Hired 32 people to build QC department
  • Introduced In-Sourcing model to Gilead Biologics and hired 15 Eurofins Lancaster Laboratories Inc. employees; this model:
  • Allowed Full Time Employees (FTE) to prepare site for Commercial Manufacturing and Testing
  • Increased QC testing capacity by having employees cover shifts
  • Decreased TAT’s of sample results needed to continue Manufacturing from 5 days to 4 hours
  • Minimized risk to QC department current FTE head count if business decided to not continue with Commercial Manufacturing
  • Authored 150 Raw Material Specifications and 40 QC Procedures and Test Methods within a 3 month period to test and release materials for first GMP run at Gilead’s Biologics facility
  • Experienced in Contract Lab Management; Quality Agreements, Statement of Work, Purchase Orders, budgeting work, building relationships, and day to day activities
  • Managed implementation of TrackWise modules for Analytical Operations for OOS/OOT, deviations, and Environmental Monitoring
  • Co-lead Audits as Quality Control SME to support Gilead Biologics site
  • Primary point of contact for State Audit, which gave Gilead Biologics license to produce products
  • Developed, implemented, and maintained systems related to the analysis of clinical products
  • Member of the Site Leadership Team
  • Hosted QC Global Forum Meeting
  • Lead LIMS development and implementation for Gilead Biologics
  • Experienced in systems that drive Biopharmaceutical businesses such as: Oracle, SAP, LIMS, TrackWise, Documentum, GxP Learning, and Performance Management

Genentech, Inc.

1 Antibody Way, Oceanside, CA 92056 September 2011-December 2005

Supervisor, Quality Control (March 2007-September 2011)

  • Supervised and developed up to 7 direct reports regarding Quality Control testing, Good Manufacturing Practices, and career development
  • Managed the Genentech Clinical Plant, Commercial Sterility Testing, and Sample Management
  • Improved company efficiencies by transferring Clinical product testing to the Commercial QC labs; trained Clinical and Commercial staff on test methods so samples could be batched
  • Authored Corrective and Preventative Actions that increased efficiencies across departments and decreased Environmental Monitoring Over Action Levels
  • Identified audit risks at commercial and clinical facilities and lead appropriate changes
  • Served as Single Point of Contact for Quality Control for Oceanside Clinical Plant and Oceanside Sterility Testing by attending site and network meetings, providing a Quality Control perspective, and completing data packets, reports, and other time sensitive material "on time" and "right first time”
  • Participated in workforce planning with management team by developing recommendations, evaluating alternatives, and implementing plan for reduced headcount
  • Managed excellent performance of team by hiring, firing, coaching, developing, and believing that all employees deserve a great manager
  • Developed Quality Control Open House to increase customer satisfaction; this concept was then implemented in other departments because of the incredible return on investment it had within QC
  • Represented all areas of expertise during internal and external audits by participating in tours, presenting data to auditors, discussing Standard Operating Procedures and Validations and developed employees' audit skills
  • Developed Campaign Readiness Meeting for customers and suppliers, which resulted in educated staff that were able to deliver a quality clinical product
  • Selected for the Personal Excellence Program Pilot at Genentech, which allowed for substantial growth professionally and personally

Analyst II, Quality Control (December 2005-March 2007)

  • Approved data for Genentech's Water Systems, Gas Systems, and Environmental Monitoring Program
  • Developed training course for LIMS and trained all new LIMS users
  • Performed and trained as a lead trainer on: bioburden, endotoxin, growth promotion, and sterility testing
  • Validated the Sterility Suite at Oceanside, which allowed Genentech Oceanside to support network testing
  • Developed Quality Control Core Skills for new hires

Biogen Idec (IDEC)

1 Antibody Way Oceanside, CA 92056 November 2002-December 2005

Associate II, Quality Control (January 2004-December 2005)

  • Executed validations, IQ/OQ/PQ's, and test scripts to allow LIMS to be used
  • Managed all aspects of Reverse Osmosis validation projects which included: writing deviations and final reports, learning the overall layout of the water systems, and meeting with engineers to discuss sampling options
  • Wrote Standard Operating Procedures and Performance Qualifications for the QC Microbiology department
  • Trained new employees and coworkers on endotoxin, growth promotion, bioburden, environmental monitoring, biological indicators, and coliform testing
  • Certified as QC Microbiology's Qualified Trainer
  • Responsible for troubleshooting LIMS, providing daily instruction to coworkers, and ensuring reports have accurate and precise data

Analyst I, Quality Control (November 2002-January 2004)

  • Performed Microbiological tests including: bioburden, biological indicators, and environmental monitoring
  • Validated IDEC's Clinical facility
  • Revised Standard Operating Procedures
  • Served as LIMS super-user for Quality Control department

EDUCATION

Bachelor of Liberal Arts, Human Biology - University of Kansas, Lawrence, KS