Melissa Daugherty
Bourbonnais,IL
Summary
Experienced Project Management Professional with over 20 years in Pharmaceutical Biomanufacturing operations, quality, and R&D project leadership. Proficient in relationship-building, communication, and problem-solving as a global cross-functional/organizational leader. Demonstrated success in implementing business strategies through effective project management, with expertise in rescuing and delivering large capital projects by engaging stakeholders, aligning resources, and executing strategic priorities.
Overview
25
25
years of professional experience
Work History
Associate Director R&D Management
CSL Behring
06.2013 - Current
- Returned to CSL Behring as Process Manager progressively promoted to Associate Director
- Successfully applied PMP methods to successfully lead 30+ projects over 12 years ranging from $20M scope up to $690M scope
- Led Multiple Global Product Launches, maintaining positive relationships with Supply Chain Partners and External Contract Manufacturing Operations
- Expert at proactively identifying program risks to drive the preparation of mitigation/resolution plans
- In depth knowledge and understanding of relevant therapeutic area knowledge as related to project/program/products
- In depth knowledge of drug development and manufacturing processes for CMC, Non-Clinical, Clinical, and Regulatory Affairs
- Successfully collaborates with SME’s across the organization including C&Q, Validation, Marketing & Commercial, Network Strategy, R&D, Product Development, Enterprise Portfolio Management, Quality and Regulatory to deliver new product launches, capacity expansions and other operational improvements to benefit CSL
- Executive presentation skills supporting effective procurement and funding and strategy approval for projects up to $690M
- Tapped on to lead the Prefilled Syringe Leadership Team developing strategy, ensuring alignment across portfolio while working with TALT, PST and Global Commercial Operations for the US Market
- Led project team bringing drug product from R&D development to clinical trials to commercial manufacturing
- Led several Technical Transfers across CSL Network as well to external partners from Construction, C&Q, Validation to Regulatory submission and implementation.
- Add a few more things here
Chemical Process Engineer
Armstrong World Industries
10.2011 - 06.2013
- Provided formulation technical support to all production lines, supported deviation investigations, and assured the consistent quality manufacture of products
- Drafted, edited, reviewed, and executed Standard Operating Procedures (SOP’s), Manufacturing Production Records (MPR’s), and Change Controls
- Proactively tracked and trended data, utilizing SPC guideline, associated with process performance and quality attributes
- Worked to improve manufacturing quality and productivity through process optimization of both yield improvements and streamlining through the implementation of new and innovative processes.
- Drove raw material cost reductions of $1M to achieve annual goal for site
- Selected Contributions:
- Implement process improvement to remove human interaction when making sterile connections to decrease the potential of human contamination
- Trained all union and non-union personnel is minimal amount of time to sterile fill the H1N1 Vaccine to meet government requirements
- Implemented process improvements to decrease cycle time by 10% to increase output to meet production demands
Process Scientist
CSL Behring-Operations
05.2009 - 10.2011
- Provided technical support to manufacturing departments, supported deviation investigations, and assured the consistent quality manufacture of products
- Drafted, edited, reviewed, and executed Standard Operating Procedures (SOP’s), Manufacturing Production Records (MPR’s), and Change Controls
- Proactively tracked and trended data, utilizing SPC guideline, associated with process performance and quality attributes
- Worked to improve manufacturing quality and productivity through process optimization of both yield improvements and streamlining through the implementation of new and innovative processes.
- Key contributor during Internal and External Audits (FDA)
- Selected Contributions:
- Integrate new $3M product line into existing operations
Quality Engineer
CSL Behring Quality Assurance
04.2007 - 05.2009
- Driver of results to Key Process Indicators (KPI’s) utilizing SPC guidelines to maintain process conditions in a state of control
- Serve as Subject Matter Expert (SME) for Aseptic Manufacturing during regulatory audits and investigations of process, environmental, and equipment deviations
- Initiate and implements Corrective and Preventative Actions (CAPA’s) for Department
- Lead & manages activities of Quality Specialists to ensure compliance to regulations, product license, and procedural specifications
- Perform departmental and facility audits to ensure regulatory compliance
- Creates Annual Product Report to the FDA for department
- Aseptic filling process knowledge involving syringe and vial filling and lyophilization
- Defines manufacturing processes in written procedures (SOP’s and MPR’s)
Supervisor & Process Manager
CSL Behring-Operations
02.2003 - 04.2007
- Provided technical support to manufacturing departments, supported deviation investigations, and assured the consistent quality manufacture of products
- Drafted, edited, reviewed, and executed Standard Operating Procedures (SOP’s), Manufacturing Production Records (MPR’s), and Change Controls
- Proactively tracked and trended data, utilizing SPC guideline, associated with process performance and quality attributes
- Worked to improve manufacturing quality and productivity through process optimization of both yield improvements and streamlining through the implementation of new and innovative processes.
- Coordinate activities of union production operators to assure safe, timely, efficient, and compliant manufacture of quality products in accordance with policy and procedures
- Drafted, edited, reviewed, and executed Standard Operating Procedures (SOP’s), Manufacturing Production Records (MPR’s), and Change Controls
- Assisted in training of production operators
Microbiology QC Analyst
CSL Behring- Quality Control
04.2000 - 02.2002
Education
Certified Project Management Professional -
Project Management Institute (PMI)
12.2020
Masters of Business Administration -
Olivet Nazarene University
Bourbonnais, IL08.2003
Bachelors of Science - Major Chemistry
Georgia State University
Atlanta, GA05.1999
Skills
- Project & Portfolio Management
- Technology transfer
- Root Cause Analysis & Corrective Action
- Cross-functional Team Leadership & Global Collaboration
- Strategic Planning & Implementation
- Global Regulatory Compliance
- Budget Management ($10mm -$690mm)
- Technical Writing Skills
- Aseptic Processing expertise & Quality Management Systems
- Operations and Productivity Improvement
- Executive Presentation Skills
- Advanced Problem Solving
- Business Acumen & Risk Management
Timeline
Associate Director R&D Management
CSL Behring
06.2013 - Current
Chemical Process Engineer
Armstrong World Industries
10.2011 - 06.2013
Process Scientist
CSL Behring-Operations
05.2009 - 10.2011
Quality Engineer
CSL Behring Quality Assurance
04.2007 - 05.2009
Supervisor & Process Manager
CSL Behring-Operations
02.2003 - 04.2007
Microbiology QC Analyst
CSL Behring- Quality Control
04.2000 - 02.2002
Certified Project Management Professional -
Project Management Institute (PMI)
Masters of Business Administration -
Olivet Nazarene University
Bachelors of Science - Major Chemistry
Georgia State University
Similar Profiles
Amy RuppAmy Rupp
Associate Director, Adaptive Clinical Trial Technology at CSL BEHRINGAssociate Director, Adaptive Clinical Trial Technology at CSL BEHRING
Rodney WinleyRodney Winley
Head, R&D Patient Partnerships at CSL BehringHead, R&D Patient Partnerships at CSL Behring
Kari WilliamsKari Williams
Global Regulatory Affairs Scientist at CSL BehringGlobal Regulatory Affairs Scientist at CSL Behring
Carrie NorrisCarrie Norris
Manager of Team Member Experience at Cooper's Hawk Winery and RestaurantManager of Team Member Experience at Cooper's Hawk Winery and Restaurant
Katelyn WatsonKatelyn Watson
Emergency Room Registered Nurse at St. Mary HospitalEmergency Room Registered Nurse at St. Mary Hospital