Project Manager Process

Joanna Kahl, Ph.D.

dswm2h@r.postjobfree.com •cell: 317-***-****

Experienced Quality Validation Manager

Compliance ~ Project Management ~ Quality Improvements ~Change Management

A results-oriented business professional with expertise in strategic project management to drive large scale cross-functional team collaborations for problem solving and process improvement in full compliance with organizational, federal, and international regulations.

PROFESSIONAL EXPERIENCE

CSL Behring, Strategic Initiatives

Manager, Process Validation Sept. 2011-Present

Oversaw $6M budget for 4 scientists and industry consultants to develop a strategy to deliver compliant validation packages for a successful inspection and on time to meet business plans

• Directed process & cleaning validation activities for 3 yr, $144 million dollar technology transfer expansion project for biopharmaceutical company.

o Core areas: Facility (HAVC and environmental monitoring), Utility (WFI, N2, CCA, Pure Steam), Sanitization program, Mixing, Filtering, Final Formulation, Aseptic Filling, VHP Isolator, Media Fills, and Comparability/Stability Studies

• Proven ability to rapidly understand, develop and deploy innovative approaches against challenging objectives. Leadership across all quality functions; 8+ years specialized experience in validation

• Developed documentation for Type C meeting with FDA

• Participate on large global team to support technology transfer project

• Support the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance).

• Provide leadership to generate support and effectiveness throughout the organization.

Roche Diagnostics Operations, Centralized Diagnostics

Manager, Process Validation June 2006-December 2010

Oversaw $2M-11M budget for 6 scientists and 35+ industry consultants to drive implementation and execution of validations as well as provide support to departments for new product launches and process changes

• Directed process validation activities for a 4 yr, multi-million dollar remediation project resulting in on time within budget completion of validations in conformance with federal and ISO regulations

• Developed and implemented an innovative strategy to validate a new cleaning process for a multi-product (300) facility with shared equipment; led a team of 8 scientists in the execution of the studies under urgent timelines, condensed 300 products into 3 validation runs that demonstrated process capability

• Managed a team of 5 engineers to develop and execute laboratory equipment qualification protocols; identified a deficiency with handling electronic data so a strategy was developed to bring these systems up to 21CFR Part 11 compliance

• Developed long term strategy and created implementation plans, collaborated with local managers to monitor and review critical process quality data, ensuring manufacturing operations remained in a state of validation compliance; tracked and monitored CAPA cases, reported quality metrics to raise awareness and drive process improvements

• Audited and reviewed >3500 validation packaged for utilities, equipment, computer systems, methods, spreadsheets, software, products, and processes; thus becoming the business area expert

• Standardized and streamlined the validation review process leading to increased customer satisfaction & first-pass acceptance and reduced cycle times by 30%

• Implemented a campus wide change control program to ensure a sustained state of compliance for validated processes and systems

• Provided troubleshooting support to help identify the cause of product/production related problems and provided changes to improve product/processes. Reduced repeat problems and continually improved processes to ensure minimal impact to the supply chain.

• Fully responsible for the validation program: created new SOPs and Validation Master Plan, reviewed and improved procedures to increase efficiency and meet appropriate regulatory agency validation requirements, internal company standards, and current industry practices; expert on process/cleaning validation leading to successful inspections

• Cultivated a culture where people challenged status quo and created innovation with the goal of providing high quality products and being a industry leader in compliance

• Local project manager for global team of 20+ managers/directors that was responsible for site transfer and closure of all manufacturing operations. On time site transfer supported business continuity and millions in cost savings; developed global relationships and facilitated transfer of information

Process Validation Scientist November 2004- June 2006

Equipment, method, and process engineer (scientist) responsible for leading a team of 6 scientists/engineers through the qualification of legacy laboratory equipment. Also responsible for providing key validation input to support R&D/QA/Technical projects.

• Contributed to the creation and development of a new department: developed & supported the introduction of new or improved methods, procedures, processes and programs; innovated for simplicity

• Effectively wrote and executed qualification protocols (IQ, OQ) for analytical laboratory equipment and validation deliverables (PQ, PV) for new and existing processes in a cGMP/CDRH regulated medical device manufacturing environment; developed and executed the first validation protocol under the new Validation Program, recognized as industry best

• Provided validation training to project leaders resulting in increased first pass acceptance quality metrics

Technical Affairs Product Support Scientist June 2002-November 2004

Provided analytical support to Operations and technical input for new product design and pilot production. Supported the business area by performing troubleshooting investigations, and developing and implementing process improvements.

• Provided technical expertise, developed manufacturing instructions and standard operating procedures for new product design and manufacturing capability (clinical chemistry, immunochemistry therapeutic drug monitoring) resulting in robust and efficient processes that were implemented

• Supported high value customers by resolving technical issues with products; saved relationship with customer account and improved the performance of the product

• Expanded service offerings by providing technical training to internal customers

• Implemented process improvements 50K-250K; demonstrated strong scientific/engineering skills

ACADEMIC EXPERIENCE

Department of Biochemistry, University of Illinois

Graduate Assistant 1995-2004

Developed an understanding of the structural-functional role of key proteins during synaptic differentiation. Specifically, at the vertebrate neuromuscular junction, results demonstrated that overexpression of the subunit of dystroglycan in cultured muscle cells inhibits agrin-induced AChR clustering. Deletion analysis and point mutagenesis demonstrated that the inhibition is mediated by an intracellular, juxtamembrane region composed of basic amino acids. Finally, the inhibition mediated by -dystroglycan extends to the minimal agrin fragment required for AChR clustering, suggesting that dystroglycan plays an important role in postsynaptic differentiation in response to agrin. Studies were performed using

Molecular Biology Mammalian Cell Biology ● DNA subcloning & purification ● COS,CHO,C2C12transfections

● PCR ● protein overexpression

● DNA sequencing ● radiolabel proteins

Biochemistry Immunoapplication

●Protein assays ● immunocytochemistry

● polyacrylamide gel electrophoresis ● flow cytometry

● cellular fractionation ● immunoprecipitations

● chemical crosslinking ● fluorescence microscopy

EDUCATION AND TRAINING

Ph.D.-Biochemistry, 2004, University of Illinois, Urbana, Illinois

B. S.-Chemical Engineering, 1995, Purdue University, West Lafayette, Indiana

Institute of Validation Technology-Process and Cleaning Validation Training

AAMI, AdvaMed, CfPA, and CfPIE Validation Training

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