Kevin Bittorf Email & Phone Number

SCxCMC Solutions has assembled a highly skilled group of consultants to help bring our pharmaceutical client’s molecules to the clinic efficiently while exceeding expectations and timelines. Our talented group of consultants include experts in Formulation Development, Chemical Development, Chemistry, Quality Assurance, Project Management, Supply Chain.

CMC Consultant experience in wide rage of dosage forms: Tablets, Softgets, Emulsions, sprays, nano-particles and solutionsHighly experienced in working with CMO and CRO in attaining clinical trial material and commercial material.

The Advancing Drug Development Forum - Making the Impossible Possible, builds on positive momentum and energy from our past meetings. Our Next form is Dec 12th, 2019 in Boston MA,The form attracts and stimulates dialogue among key opinion leaders within biotech and pharma, executive leaders, senior directors, consultants, and a close network of CROs and.

Founding President of an organization to examine pharmaceutical compactions. Simulation/replication of tablet compression is an increasingly important part of product development, allowing investigation of tableting properties earlier in development and material/cost sparing studies supporting scale-up and registration. Now widely used in the.

Greenbrae, California, US

At NP2, a non-profit dedicated to reducing the cost of life-saving generic drugs in the U.S., I led the strategic effort to bring affordable oncology medications to market, specifically targeting injectable generic drugs that have seen significant price increases in recent years. I provided leadership in identifying CDMO partners for a.

Lexington, Massachusetts, US

In my role as Acting Head of CMC, I was responsible for preparing all active assets for commercialization while ensuring the continuous supply of clinical trial materials for both large and small molecule programs. I led the CMC team in successfully managing critical operational and strategic initiatives to advance Curis' portfolio.Key accomplishments.

Charlestown, MA, US

As the Scientific Fellow and Head of Formulation Development at Flatley Discovery Lab, I spearheaded the development of a complex formulation for a combination product targeting cystic fibrosis. I led the end-to-end formulation process, from initial development through manufacturing, to ensure the successful delivery of clinical trial materials. This.

• As Vice President at Trek Therapeutics, I held comprehensive responsibility for all pharmaceutical development (CMC), supply chain management, business development, and intellectual property activities. This included.
• Developed and led the virtual pharmaceutical development (CMC) network of CMOs and CROs to ensure efficient development and manufacturing of clinical and commercial materials.
• Provided the operational framework for financial and project management functions, ensuring seamless execution of development strategies.
• Successfully negotiated terms and managed contracts for all of Trek’s assets, forming the foundation of our Hepatitis-C treatment program

• As the Industrial Chair and Advisory Board Member, I provide strategic leadership and guidance to advance the organization's mission of fostering innovation and collaboration within the biopharmaceutical sector. In.
• Led the formation of strategic industry-academic partnerships, enhancing the consortium's impact on biopharmaceutical innovation.
• Advised on the development of cutting-edge biomanufacturing technologies to improve product robustness and safety.
• Facilitated industry engagement, securing funding for research projects and new infrastructure developments that support advanced biopharmaceutical science.

Boston, MA, US

• I was responsible for expanding overall understanding of Living proof’s products and processes. Completing this thought a quality by design (QbD) framework and developing advanced analytical technologies to assist in.
• Reduced release time for products by over 90%
• Reduced batch failure by over 80%
• Developed a formal project management system

Boston, MA, US

• Develop Assets in Emerging Markets
• Developed and directed a virtual Chemistry Manufacturing and Control (CMC), group
• Key contributor to Vertex’s creation of a network model to develop novel compounds through partnershipsAssess and Implement Novel Technologies for Pharmaceutical Development: Continuous Processing
• Initiated the continuous processing initiative for Vertex Pharmaceuticals’ products; all of Vertex’s products will be manufactured in this manner. Completed the technical and financial justification to move all project.
• Led Pharmaceutical Development innovation teams to identify future processing technologies in the areas of biotransformations, finite element analysis, continuous processing, and process analytical technology (PAT)

Boston, MA, US

• Led the formulation development for Vertex’s anti-viral compounds including, Incivek, Vertex’s oral treatment for hepatitis C (HCV). CMC Core Team Leader for HCV programs. Key accomplishments:
• Developed a “Quality by Design” (QbD) framework for our contract manufactures
• Introduced multiple real-time process analytical technologies (PAT) into the laboratory and commercial manufacturing
• Identified CMOs and transferred entire CMC activities to new manufacturers

Dublin, County Dublin, IE

• Technical Operations Engineer
• Validated over 30 products and intermediates in a cGMP environment at various CMOs
• Developed solid dosage forms with various methods including: blending, compression, coating, soft-gel encapsulation, and gelatin coating processes

DK-2740 Skovlunde, DK

Developer, consultant and sales representative for Computational Fluid Dynamics designed to solve industrial mixing problems.

Phd, Chemical Engineering

Mba

B.Sc., Chemical Engineering