Chris Hanff, CMQ/OE
Strategic Advisor at Falls River Group- Claim this Profile
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Bio
Katie Harcher
I worked extensively with Chris during his time at Athersys. Chris was truly a team player, always willing to mentor others and offer assistance. In the fast-paced and ever evolving environment at Athersys, Chris embraced new challenges and opportunities to learn. Chris managed multiple projects involving numerous multi-national organizations for which I was a scientific subject matter expert. He was very adept at establishing solid and amicable relationships between teams, leading to productive and collaborative efforts on our projects. Chris will be a huge asset to any company he works for.
Ken Kuller
Chris consistently demonstrates excellent program management skills while simultaneously strengthening his relationships with external partners. I have had the professional and personal pleasure of working with Chris over the last year. His experience, communication skills, and attention to details combined with his solution driven approach to solving challenges is refreshing and delivers results for his employer and partner. I am comfortable saying Chris is one of the best I have had the privilege of working with and he will continue to make a difference in any high performing team.
Katie Harcher
I worked extensively with Chris during his time at Athersys. Chris was truly a team player, always willing to mentor others and offer assistance. In the fast-paced and ever evolving environment at Athersys, Chris embraced new challenges and opportunities to learn. Chris managed multiple projects involving numerous multi-national organizations for which I was a scientific subject matter expert. He was very adept at establishing solid and amicable relationships between teams, leading to productive and collaborative efforts on our projects. Chris will be a huge asset to any company he works for.
Ken Kuller
Chris consistently demonstrates excellent program management skills while simultaneously strengthening his relationships with external partners. I have had the professional and personal pleasure of working with Chris over the last year. His experience, communication skills, and attention to details combined with his solution driven approach to solving challenges is refreshing and delivers results for his employer and partner. I am comfortable saying Chris is one of the best I have had the privilege of working with and he will continue to make a difference in any high performing team.
Katie Harcher
I worked extensively with Chris during his time at Athersys. Chris was truly a team player, always willing to mentor others and offer assistance. In the fast-paced and ever evolving environment at Athersys, Chris embraced new challenges and opportunities to learn. Chris managed multiple projects involving numerous multi-national organizations for which I was a scientific subject matter expert. He was very adept at establishing solid and amicable relationships between teams, leading to productive and collaborative efforts on our projects. Chris will be a huge asset to any company he works for.
Ken Kuller
Chris consistently demonstrates excellent program management skills while simultaneously strengthening his relationships with external partners. I have had the professional and personal pleasure of working with Chris over the last year. His experience, communication skills, and attention to details combined with his solution driven approach to solving challenges is refreshing and delivers results for his employer and partner. I am comfortable saying Chris is one of the best I have had the privilege of working with and he will continue to make a difference in any high performing team.
Katie Harcher
I worked extensively with Chris during his time at Athersys. Chris was truly a team player, always willing to mentor others and offer assistance. In the fast-paced and ever evolving environment at Athersys, Chris embraced new challenges and opportunities to learn. Chris managed multiple projects involving numerous multi-national organizations for which I was a scientific subject matter expert. He was very adept at establishing solid and amicable relationships between teams, leading to productive and collaborative efforts on our projects. Chris will be a huge asset to any company he works for.
Ken Kuller
Chris consistently demonstrates excellent program management skills while simultaneously strengthening his relationships with external partners. I have had the professional and personal pleasure of working with Chris over the last year. His experience, communication skills, and attention to details combined with his solution driven approach to solving challenges is refreshing and delivers results for his employer and partner. I am comfortable saying Chris is one of the best I have had the privilege of working with and he will continue to make a difference in any high performing team.
Credentials
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Leading with Intelligent Disobedience
LinkedInJul, 2022- Oct, 2024 -
Certified Manager of Quality/ Organizational Excellence
ASQOct, 2014- Oct, 2024 -
Implementation of Quality Risk Management
PDAMar, 2012- Oct, 2024 -
Qumas DocCompliance Train the Trainer certificate
QUMASNov, 2003- Oct, 2024
Experience
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Falls River Group
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United States
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Investment Banking
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1 - 100 Employee
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Strategic Advisor
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Jun 2023 - Present
Chris provides the firm education, knowledge, and experiential review of information pertaining to Biopharma manufacturing, including standards for GXP, recent trends, pricing, sourcing, scaling, macroeconomic policies, and regulatory matters affecting the Industry so that the firm may make well-informed decisions. Chris joined the firm as a Strategic Advisor for the Life Sciences sector with broad expertise in Biopharma Operations and Quality Management. In his third decade in the Life… Show more Chris provides the firm education, knowledge, and experiential review of information pertaining to Biopharma manufacturing, including standards for GXP, recent trends, pricing, sourcing, scaling, macroeconomic policies, and regulatory matters affecting the Industry so that the firm may make well-informed decisions. Chris joined the firm as a Strategic Advisor for the Life Sciences sector with broad expertise in Biopharma Operations and Quality Management. In his third decade in the Life Science industry, Chris cultivated a wide-ranging user perspective intersecting R&D, Tech Transfer, Sterile Manufacturing with both Reusable and Single-use technologies, suite Startups, Validations, and Shipping with Quality Management, including FDA Consent Decree Remediation, and Third-Party Oversight. Chris led Program and Alliance Management for international programs valued over $100M, where he led highly technical, global teams assuring the Product, Process, Quality, and Business parameters of a first-of-its-kind cell therapy Drug Product. Chris has a keen vision to architect near term solutions while simultaneously scouting a path for long term success, leading his teams to be right-first-time and cost-effective in bringing products to market that protect health. Show less Chris provides the firm education, knowledge, and experiential review of information pertaining to Biopharma manufacturing, including standards for GXP, recent trends, pricing, sourcing, scaling, macroeconomic policies, and regulatory matters affecting the Industry so that the firm may make well-informed decisions. Chris joined the firm as a Strategic Advisor for the Life Sciences sector with broad expertise in Biopharma Operations and Quality Management. In his third decade in the Life… Show more Chris provides the firm education, knowledge, and experiential review of information pertaining to Biopharma manufacturing, including standards for GXP, recent trends, pricing, sourcing, scaling, macroeconomic policies, and regulatory matters affecting the Industry so that the firm may make well-informed decisions. Chris joined the firm as a Strategic Advisor for the Life Sciences sector with broad expertise in Biopharma Operations and Quality Management. In his third decade in the Life Science industry, Chris cultivated a wide-ranging user perspective intersecting R&D, Tech Transfer, Sterile Manufacturing with both Reusable and Single-use technologies, suite Startups, Validations, and Shipping with Quality Management, including FDA Consent Decree Remediation, and Third-Party Oversight. Chris led Program and Alliance Management for international programs valued over $100M, where he led highly technical, global teams assuring the Product, Process, Quality, and Business parameters of a first-of-its-kind cell therapy Drug Product. Chris has a keen vision to architect near term solutions while simultaneously scouting a path for long term success, leading his teams to be right-first-time and cost-effective in bringing products to market that protect health. Show less
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Senior Director & Head, Program Management
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Oct 2022 - May 2023
Responsible for Program Management with Summation Bio, which is a biotech startup in stealth mode. I kicked off a program management office and managed Intellectual Property for a novel, Non-Viral Gene Therapy technology. Responsible for Program Management with Summation Bio, which is a biotech startup in stealth mode. I kicked off a program management office and managed Intellectual Property for a novel, Non-Viral Gene Therapy technology.
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Athersys
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United States
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Biotechnology Research
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1 - 100 Employee
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Head, Laboratory Operations & Senior Program Management
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2022 - Jun 2022
Laboratory Services Dept Head responsible for creating and coaching team to enable high performance of Athersys Quality Control and Analytical Development labs, including: Program and Relationship/ Alliance Management, Metrology and Validation, Environmental Control, Inventory Management, and Digital Solutions.
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Responsible for Program/ Project Management
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2018 - 2022
Responsible for designing, developing, deploying Program Management Office. Support effective new product commercialization, globally, through technology and knowledge transfer. Resolve technical and compliance issues through problem analysis. Lead projects within the organization and provide guidance to internal and external colleagues. Side project for implementation of MS Dynamics (D365) for manufacturing process parameters and final product test results. Promoted mantra: 1SOT (1… Show more Responsible for designing, developing, deploying Program Management Office. Support effective new product commercialization, globally, through technology and knowledge transfer. Resolve technical and compliance issues through problem analysis. Lead projects within the organization and provide guidance to internal and external colleagues. Side project for implementation of MS Dynamics (D365) for manufacturing process parameters and final product test results. Promoted mantra: 1SOT (1 source of truth) for integration of manufacturing process, material pedigree, QC results data, documentation and workflow management and more. Generated and coached others creating hundreds of PowerBI visualizations for deep analytics, correlations analyses, trending, SPC (statistical process control), and performance management (metrics control plan) dashboards.
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Mallinckrodt Pharmaceuticals
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Performance Excellence Leader
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Aug 2017 - Oct 2018
Delivery, Sustainability, and Growth of Mallinckrodt Performance Excellence Standards. Strategic planning and partnering with Operations and Quality leaders to recognize and maximize value through process excellence Delivery of Improvement Pipeline and Cost Saving Target through collaboration and coaching across the global network. Leading Transformation Change that efficiently and effectively enables Managing Complexity and Improving Lives. Delivery, Sustainability, and Growth of Mallinckrodt Performance Excellence Standards. Strategic planning and partnering with Operations and Quality leaders to recognize and maximize value through process excellence Delivery of Improvement Pipeline and Cost Saving Target through collaboration and coaching across the global network. Leading Transformation Change that efficiently and effectively enables Managing Complexity and Improving Lives.
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ValSource Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Consultant
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Jan 2014 - Aug 2017
ConcordiaValSource is a premier consulting services firm with a focus on applying robust life cycle model methods for Pharmaceutical, Biopharmaceutical, Medical Device, and Combination products. In his work consulting with ConcordiaValSource, Chris Hanff made successful experiences and/ or has experience to bear in the following. Designed and redesigned quality systems, with focus on risk based principles, especially in validation program and cost of quality/ performance… Show more ConcordiaValSource is a premier consulting services firm with a focus on applying robust life cycle model methods for Pharmaceutical, Biopharmaceutical, Medical Device, and Combination products. In his work consulting with ConcordiaValSource, Chris Hanff made successful experiences and/ or has experience to bear in the following. Designed and redesigned quality systems, with focus on risk based principles, especially in validation program and cost of quality/ performance monitoring. Applied industry experience and proven techniques that influenced the adoption and integration of sound validation and risk management policies and procedures. Built and enhanced pharmaceutical bulk, intermediates, final product vials and syringes shipping validation programs, created diagrams of shipping lanes and process maps, chartered and developed document based project plan. Advocated and authored risk-based shipping validation plans. Engineered PhAST (Pharmaceutical Accelerated Shipping Trials) strategy that compressed shipping validation timeline for actual journey demonstration. Risk Management, Process Validation, Quality Systems, Product and Process Knowledge, QbD, and Process Excellence. Show less ConcordiaValSource is a premier consulting services firm with a focus on applying robust life cycle model methods for Pharmaceutical, Biopharmaceutical, Medical Device, and Combination products. In his work consulting with ConcordiaValSource, Chris Hanff made successful experiences and/ or has experience to bear in the following. Designed and redesigned quality systems, with focus on risk based principles, especially in validation program and cost of quality/ performance… Show more ConcordiaValSource is a premier consulting services firm with a focus on applying robust life cycle model methods for Pharmaceutical, Biopharmaceutical, Medical Device, and Combination products. In his work consulting with ConcordiaValSource, Chris Hanff made successful experiences and/ or has experience to bear in the following. Designed and redesigned quality systems, with focus on risk based principles, especially in validation program and cost of quality/ performance monitoring. Applied industry experience and proven techniques that influenced the adoption and integration of sound validation and risk management policies and procedures. Built and enhanced pharmaceutical bulk, intermediates, final product vials and syringes shipping validation programs, created diagrams of shipping lanes and process maps, chartered and developed document based project plan. Advocated and authored risk-based shipping validation plans. Engineered PhAST (Pharmaceutical Accelerated Shipping Trials) strategy that compressed shipping validation timeline for actual journey demonstration. Risk Management, Process Validation, Quality Systems, Product and Process Knowledge, QbD, and Process Excellence. Show less
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Assoc. Director, Quality Systems
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Jun 2011 - Dec 2013
Dept. Head: Quality Investigations, Complaints, & CAPA; Quality Data Management. Department head of 20+ quality professionals. Leader of people leaders. Invented new Critical Response Team (CRT) program for escalation and efficient execution of critical investigations. Built new CAPA Board and CAPA Teams. Implemented myriad digital tools for quality, including automation of APRs (Annual Product Reviews). Served as Quality representative in significant site strategy: portfolio… Show more Dept. Head: Quality Investigations, Complaints, & CAPA; Quality Data Management. Department head of 20+ quality professionals. Leader of people leaders. Invented new Critical Response Team (CRT) program for escalation and efficient execution of critical investigations. Built new CAPA Board and CAPA Teams. Implemented myriad digital tools for quality, including automation of APRs (Annual Product Reviews). Served as Quality representative in significant site strategy: portfolio management; facility remediation scenarios; presented at FDA HQ.
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Manager, Quality Data Management
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Apr 2009 - Jun 2011
Chartered new Quality Data Management department, aligned with ICH Q10. Managed staff of 10+ professionals with multiple outputs: Annual Product Reviews; performance metrics; trend and statistical analyses. System owner of TrackWise EQMS. Responsible for quality review of Quality Risk Management and process capability assessments.
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Centocor Biologics
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United States
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Research Services
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Supervisor, Media & Buffer Production
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Nov 2006 - Jan 2009
Subject Matter Expert (SME) and Supervisor for production of sterile-packaged liquid cell culture media and down-stream processing (DSP) buffer solutions. Responsibilities include: day-to-day operations; schedule and resource management; document authoring and change management; process improvement opportunities; and, coaching. Subject Matter Expert (SME) and Supervisor for production of sterile-packaged liquid cell culture media and down-stream processing (DSP) buffer solutions. Responsibilities include: day-to-day operations; schedule and resource management; document authoring and change management; process improvement opportunities; and, coaching.
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Sigma Aldrich
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Biotechnology Research
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700 & Above Employee
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Supervisor, Liquid Media, Buffers & Sera
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2004 - 2006
Supervisor for catalog and custom production of sterile-packaged liquid cell culture media, sera products, and down-stream processing (DSP) buffer solutions. Batch equipment from 10L to 10,000L and aseptic filling in ISO Class 5 (class 100) clean rooms. Responsibilities include: day-to-day operations; schedule and resource management; document authoring and change management; process improvement opportunities; and, coaching.
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Sr. Product Transfer Specialist
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2001 - 2004
Independently solved issues of new product transfer and existing product failures through Root Cause Analysis and CAPA execution. Authored manufacturing document creation and revision. Engineered process troubleshooting experimentation and production scale implementation.
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Analytical & Process Development Scientist
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2000 - 2001
Quantified spent media samples with analytical instruments to include HPLC, CE, and biochemistry analyzer. Teamed with Manufacturing and Quality to realize “Key Customer” product specifications and timelines. Authored document revisions and trained production technicians.
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R&D Associate Scientist
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May 1999 - 2001
Conducted daily expansion and inoculation of cell cultures. Charted and presented product key performance indicators to research development peers and management. Analyzed and interpreted effects of variables versus controls.
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Education
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1994 - 1999
Truman State University
Bachelor of Science (BS) -
1990 - 1994
Christian Brothers College High School
Community
