Mark Williams
Principal Partner at Comprehensive CMC Outsourcing | Loveland, Colorado, United States
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Mark Williams serves as a Principal Partner at Comprehensive CMC Outsourcing (CCMCO), where he leverages his extensive expertise in the pharmaceutical industry to drive innovative solutions for clients facing complex challenges in Chemistry, Manufacturing, and Controls (CMC). With a robust background as a Senior Technical Consultant, Mark has successfully navigated the intricacies of formulation and process development, ensuring that products meet stringent regulatory requirements and current Good Manufacturing Practices (GMP). His leadership at CCMCO is characterized by a commitment to delivering turn-key CMC services that are not only cost-effective but also tailored to the unique needs of each client.
At CCMCO, Mark spearheads key projects that encompass the entire lifecycle of pharmaceutical development, from early-stage research and development (R&D) to the submission of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA). His proficiency in Quality by Design (QbD) principles enhances the robustness of manufacturing processes, enabling clients to achieve regulatory compliance while optimizing product quality and efficiency. Mark’s strategic oversight in technical transfer and validation processes ensures seamless transitions from development to commercial manufacturing, mitigating risks and expediting timelines.
Moreover, Mark’s collaborative approach fosters strong partnerships with contract manufacturing organizations (CMOs) and other stakeholders, facilitating comprehensive program support that aligns with clients’ goals. His deep understanding of clinical development and GxP standards positions him as a trusted advisor in the pharmaceutical landscape, making significant contributions to the successful commercialization of innovative therapies. Through his role at CCMCO, Mark continues to shape the future of pharmaceutical development, driving excellence and ensuring that clients are well-equipped to meet the demands of an ever-evolving industry.
Principal Partner at Comprehensive CMC Outsourcing in April 2012 to Present
Technical Consultant / Senior Project Manager at ProPharma Group in June 2011 to December 2022
CMC Consultant at self employed in June 2010 to April 2012
Director, Pharmaceutical Manufacturing and Technology at MYRIAD PHARMACEUTICALS, INC. (Myrexis Pharmaceuticals, Inc.) in October 2006 to June 2010
Senior Scientist at APTUIT, LLC in January 2005 to November 2006
Associate Scientist at QUINTILES, INC in October 2002 to January 2005
Senior Scientist II, Manager, Group Leader, Process Scientist III, II at GENEVA PHARMACEUTICALS, INC in June 1997 to August 2002
Formulator at HOECHST MARION ROUSSEL, INC in January 1995 to June 1997
Formulator at MARION MERRELL DOW, INC in June 1989 to January 1995
Senior Technician, Development Technician III, II at MARION LABORATORIES, INC in June 1976 to June 1989
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Process Optimization
Formulation Development
Pharmaceutical Development
Technology Transfer
Manufacturing Management
Manufacturing Operations
Project Management
Troubleshooting
Product Development
Formulation
GMP
Pharmaceutics
Validation
CRO
CMC
Pharmaceutical Industry
Quality Assurance
Oncology
Sterilization
Change Control
Sop
Cleaning Validation
Quality Auditing
GxP
Quality by Design
Contract Manufacturing
Aseptic Processing
Clinical Development
Regulatory Requirements
IND
NDA
Drug Development
CAPA
FDA
R&D
GLP
Process Simulation
Analytical Chemistry
V&V
Regulatory Affairs
21 CFR Part 11
Regulatory Submissions
Trackwise
Drug Delivery
Pharmaceutical Manufacturing
eCTD
ICH guidelines
Cross-functional Team Leadership
ANDA
Manufacturing Operations Management
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Discover more about Comprehensive CMC OutsourcingWhat is Mark Williams email address?
Email Mark Williams at [email protected] and [email protected]. This email is the most updated Mark Williams email found in 2026.
What is Mark Williams phone number?
Mark Williams phone number is +18016715394 and +18017077613.
How to contact Mark Williams?
To contact Mark Williams send an email to [email protected] or [email protected]. If you want to call Mark Williams try calling on +18016715394 and +18017077613. (updated on October 30, 2024)
What is Mark Williams net worth?
Mark Williams has an estimated net worth of $150,000 to $249,999
What company does Mark Williams work for?
Mark Williams works for Comprehensive CMC Outsourcing
What is Mark Williams's role at Comprehensive CMC Outsourcing?
Mark Williams is Principal Partner
What industry does Mark Williams work in?
Mark Williams works in the Pharmaceutical Manufacturing industry.
Mark Williams Email Addresses
Mark Williams Phone Numbers
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