Your Bioanalysis Partner
for End-to-End Biologic Development
Your Bioanalysis Partner for End-to-End Biologic Development
We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.
We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.
We help mid to large pharma unify their analytical workflows, eliminate inefficiencies, and meet regulatory expectations across every phase of development.
WHY IBIO CONSULTING?
WHY IBIO CONSULTING?
Why Pharma Chooses iBio Consulting
Your Bioanalysis Partner for End-to-End Biologic Development
We help pharmaceutical teams overcome analytical complexity with a coordinated, regulatory-ready approach built for biologics.




Expertise in Mass Spectrometry and Analytical Techniques
With decades of experience in LC-MS/MS and advanced analytical platforms for large molecules, we guide method development, validation, and troubleshooting across complex modalities. Our support ensures your assays meet the highest scientific and regulatory standards from preclinical through commercial stages.




Strategic Oversight from Bench to Submission
We provide end-to-end oversight for method transfers, CRO/vendor management, and regulatory submissions. Whether you're preparing for commercialization or navigating complex tech transfers, we serve as a trusted partner ensuring scientific integrity and business alignment.




Scalable Quality Systems Built for Growth
We assess and enhance your lab’s quality framework to support evolving regulatory demands and business expansion. From SOP development to audit readiness, our approach ensures data integrity, inspection preparedness, and sustainable compliance at every stage.




Customized Training and Team Development
We empower your staff through tailored training programs in analytical techniques, regulatory expectations, and operational best practices. Whether upskilling scientists or coaching lab leaders, we build technical confidence and cross-functional capability across your team.
We empower your staff through tailored training programs in analytical techniques, regulatory expectations, and operational best practices. Whether upskilling scientists or coaching lab leaders, we build technical confidence and cross-functional capability across your team.
SERVICES
SERVICES
Expert Consulting Built for the
Complexity of Biologics
Expert Consulting Built for the Complexity of Biologics
Whether you need full analytical oversight or targeted support, we offer a deep bench of scientific, regulatory, and operational services tailored to your biologic development challenges.
Whether you need full analytical oversight or targeted support, we offer a deep bench of scientific, regulatory, and operational services tailored to your biologic development challenges.
1.
Lab Operations
From SOP development to technical team coordination, we streamline lab workflows and manage third-party vendors to maximize operational efficiency across your programs.
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
Operational Efficiency and Lab Management
Technical SOP Writing and Review
CRO/CDMO Oversight
Strategic Planning and Growth
Method Validation Documents Writing and Review
2.
Quality
We help pharma organizations design, evaluate, and operationalize GxP-compliant quality systems—ensuring regulatory readiness, data integrity, and seamless inspection outcomes.
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
GxP Compliance and Readiness
Quality System Design & Operation
Auditing Services
Data Integrity Evaluation
Method Lifecycle Oversight
Training and SOP Development
Regulatory Support and Remediation
TESTIMONIALS
Trusted by Pharma Teams
Who Value Precision and Partnership
From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
TESTIMONIALS
Trusted by Pharma Teams Who Value Precision and Partnership
From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation—his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation—his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation—his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation—his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
TESTIMONIALS
Trusted by Pharma Teams
Who Value Precision and Partnership
From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
TESTIMONIALS
Trusted by Pharma Teams
Who Value Precision and Partnership
From early-stage program design to regulatory submission, our clients rely on iBio Consulting for deep scientific insight, operational clarity, and results that move programs forward with confidence.
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
"Under Dr. Joe Nawrocki’s leadership, our bioanalytical operations saw measurable transformation - his team achieved up to 80% productivity gains and saved over $100K annually through strategic process improvements, all while expanding scientific capabilities and driving consistent value across the organization"
Christopher W. Gregory
Director of Research Technologies, UNC-Chapel Hill
“Joe played a critical role in delivering high-quality large molecule characterization and scientific guidance to our partners at Catalent. He consistently demonstrated sharp analytical thinking, strong leadership, and a strategic mindset that drove site-wide success year after year. Joe’s ability to lead teams, manage budgets, and mentor peers, combined with his contagious enthusiasm, makes him a rare blend of technical excellence and people leadership.”
Michael Merges
Vice President of Analytical Development, Autolus Therapeutics
“I’ve worked with Joe for over 15 years, and every collaboration felt like a true partnership. His deep expertise in analytical chemistry and protein characterization, paired with his problem-solving mindset and calm under pressure, consistently led to productive and scientifically sound outcomes. Joe is not only a dedicated scientist but also a thoughtful mentor and collaborative leader. His professionalism, clarity, and commitment make him an asset to any team.”
Mary Ram
Director of Quality Control, Avid Bioservices
“Joe has a strong scientific foundation and excellent leadership skills. He’s highly experienced in structural characterization, particularly in LC-MS and LC-MSMS applications and instrumentation. Many complex projects were successfully completed under his direction thanks to his sharp problem-solving abilities. As a director, he mentors and manages his team in a way that brings out their full potential. Joe is dedicated, well-organized, and a true pleasure to work with. I recommend him without hesitation.”
Kai Zhang
Software Product Owner, Agilent Technologies
“Joe is an outstanding scientist with a deep passion for his work and exceptional attention to detail. He has personally led and executed studies that solved highly complex protein characterization challenges, earning recognition from both clients and regulators. Any organization looking to build or expand its biopharmaceutical characterization capabilities would benefit greatly from his expertise.”
Curtis Monnig
Vice President CMC, Regulus Therapeutics
“Dr. Nawrocki is a knowledgeable and collaborative scientist who consistently supports quality and compliance. He works closely with the QA team to ensure his group meets cGMP standards, and his team reliably delivers high-quality projects on time. It has been a privilege to work with him, and I strongly recommend him for any future opportunity.”
Joyce Riney
Independent Quality Consultant, BioPharma Quality Consulting
ABOUT
Led by Deep Expertise.
Focused on Biologics. Trusted by Pharma.
Expert Consulting Built for the Complexity of Biologics
With over 23 years in the biologics CDMO space and 350+ client programs supported,
Joe’s expertise is both deep and proven across high-stakes environments.
With over 23 years in the biologics CDMO space and 350+ client programs supported,
Joe’s expertise is both deep and proven across high-stakes environments.
MEET THE FOUNDER
Dr. Joe Nawrocki brings over 23 years of experience as a senior scientific leader in the biologics CDMO space. As a Director of Analytical Sciences, he has provided expert support to more than 350 biopharma clients, guiding their programs from CMC development through commercial launch.
Joe specializes in analytical method development, transfer, and validation for drug substances and drug products. He’s known for combining deep scientific knowledge with regulatory awareness, operational efficiency, and the ability to solve complex technical challenges under pressure.
His leadership has helped organizations optimize lab operations, improve compliance, mitigate risk, and deliver consistent value across all phases of development. iBio Consulting was created to offer that same clarity, structure, and expert insight to mid and large-scale pharma teams working with biologics.
KEY EXPERTISE
Analytical Strategy for Biologics:
Expert in designing end-to-end analytical frameworks that guide complex biologics from development through commercialization.
Protein Characterization & Mass Spectrometry:
Deep hands-on experience with advanced techniques like LC-MS and LC-MSMS for solving high-stakes structural challenges.Regulatory Submission Support:
Proven success in preparing and reviewing analytical sections for INDs, BLAs, and other global regulatory filings.GxP Compliance & Quality Integration:
Strong track record of aligning scientific operations with cGMP standards and working closely with QA to ensure audit readiness.Scientific Leadership & CRO/CDMO Oversight:
Led high-performing teams and managed global vendor partnerships, driving quality outcomes, operational efficiency, and strategic alignment.
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CONTACT
CONTACT
Let’s Talk About Your Bioanalytical Challenges
Whether you're preparing for a regulatory submission, scaling your analytical operations, or need expert insight on complex biologics, we're here to help. Start the conversation today.
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