Kevin Bittorf Email and Phone Number
Kevin Bittorf's Location
Boston, Massachusetts, United States, United States
Kevin Bittorf's Contact Details
Kevin Bittorf work email
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Kevin Bittorf personal email
n/a
Kevin Bittorf phone numbers
About Kevin Bittorf
Kevin is a founder and principal consultant at SCxCMC, a consultancy firm that provides end-to-end solutions for clinical and commercial products. He has over 20 years of experience in the pharmaceutical industry, and is an expert in CMC, formulation development, project management, quality assurance, and supply chain management. He works with a team of highly skilled consultants to help his clients bring their molecules to the clinic efficiently and effectively, while exceeding expectations and timelines.He is also a chief manufacturing officer at NP2, a non-profit pharmaceutical organization that aims to bring down the costs of generic drugs in the United States. He is a co-founder and leader of several initiatives and organizations that advance drug development, improve patient access, and foster education and collaboration in the pharmaceutical industry. He is passionate about leveraging his expertise in CMC, formulation development and continuous manufacturing to drive positive change and impact.
Kevin Bittorf's Current Company Details
Kevin Bittorf Work Experience Details
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Founder And Principal ConsultantScxcmc Jun 2023 - PresentSCxCMC 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 Management, and other critical support functions needed for any small to medium Pharmaceutical companies and Biotechs.
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Cmc ConsultantSimulation Llc Sep 2014 - PresentCMC 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.
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Co-Founder Of Advancing Drug Development ForumAdvancing Drug Development Forum Jun 2017 - PresentThe 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 CDMOs to further explore novel solutions, and promising technology breakthroughs. Together we will learn from entrepreneurial industry experts about how they are introducing and incorporating novel approaches in small molecule drug development; changing timelines and ROIs. Hear for yourself, how you can speed up your timelines and improve your product quality. For the agenda please goto www.AdvDrug.org -
President And FounderCompaction Simulation Forum Oct 2011 - PresentFounding 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 pharmaceutical industry and in academia, simulators have a central role in pursuing Quality by Design as a time- and cost-efficient complement to on-press experimentation.www.compactionsimulation.com -
Chief Manufacturing OfficerNp2 - Pharma Reimagined Jan 2021 - Aug 2024Greenbrae, California, UsAt 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 challenging-to-manufacture cytotoxic drug and significantly boosted NP2's social media presence, doubling our outreach within a short period.I played a key role in identifying and securing potential commercialization partners and distributors, and I provided the strategic roadmap to position NP2 for a successful ANDA (Abbreviated New Drug Application) filing. My efforts helped advance NP2's mission of delivering cost-effective, life-saving treatments to those in need. -
Head Of CmcCuris Apr 2019 - Mar 2024Lexington, Massachusetts, UsIn 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 included collaborating closely with the CFO to align CMC activities with a stringent start-up budget, completing due diligence on a biologics program, and identifying and negotiating with key commercial drug product and drug substance vendors. Additionally, I implemented an IRT system to streamline clinical trial operations and defined the CMC-QA strategy to ensure regulatory compliance and quality control. -
Scientific FellowFlatley Discovery Lab Oct 2017 - Feb 2020Charlestown, Ma, UsAs 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 involved collaborating closely with cross-functional teams to navigate the unique challenges of combining multiple active pharmaceutical ingredients.In addition, I defined and managed the clinical supply chain, ensuring timely and efficient delivery of all clinical supplies across multiple trial phases. My leadership in operational logistics, coupled with a deep technical understanding of formulation science, was critical in advancing the product's clinical development and supporting its path toward commercialization. -
Vice President: Cmc, In-Licensing, And Contracting(Co-Founder)Trek Therapeutics, Pbc Oct 2014 - Sep 2018As 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 spearheading in-licensing deals and managing legal aspects of IP and contracting. I developed the strategic framework for Trek’s business development, focusing on delivering unique value propositions to potential partners, which became central to the company's deal-making process.I played a key role in Series A investor meetings, contributing to securing critical funding. Within my first three months, I secured an agreement for Trek’s first corporate asset and led the negotiation and contracting of all assets related to Trek’s Hepatitis C treatment, a cornerstone of our product portfolio.Key accomplishments include:• 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
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Industrial Chair And Advisory Board MemberBiopharmaceutical Process And Quality Consortium (Bpqc), Umass Lowell Aug 2011 - Jan 2016As 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 this role, I act as a bridge between industry and academia, ensuring that research initiatives align with real-world challenges and opportunities in biopharmaceutical manufacturing.I work closely with key stakeholders, including manufacturers, system suppliers, and raw material providers, to drive the development of next-generation biopharmaceutical processes. My efforts are focused on facilitating partnerships, shaping the research agenda, and providing insights to accelerate the commercialization of safe, effective biopharmaceutical therapeutics.Key contributions:• 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.
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Vice President: Process Development And Analytical TechnologiesLiving Proof, Inc. Mar 2013 - Jul 2014Boston, Ma, UsI 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 understanding both chemical and physical analytical mechanisms in the hair and skin lines. Responsible for product quality assurance and developed qualtiy systems. key accomplishments• Reduced release time for products by over 90%• Reduced batch failure by over 80%• Developed a formal project management system -
Strategic Development Networks: Cmc And Alliance ManagementVertex Pharmaceuticals Apr 2010 - Mar 2013Boston, Ma, UsDevelop 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 to a continuous processing platform. • 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) -
Formulation DevelopmentVertex Pharmaceuticals Jul 2005 - Apr 2010Boston, Ma, UsLed 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
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Research EngineerPerrigo Jan 2003 - May 2005Dublin, County Dublin, IeTechnical 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 -
Applications EngineerDantec Dynamics Jun 2001 - Nov 2002Dk-2740 Skovlunde, DkDeveloper, consultant and sales representative for Computational Fluid Dynamics designed to solve industrial mixing problems. -
Project EngineerPcr Company Oct 2000 - Jun 2001
Kevin Bittorf Skills
Gmp
Formulation
Quality By Design
Design Of Experiments
Cross Functional Team Leadership
Contract Manufacturing
Ind
Fda
Biotechnology
Regulatory Filings
Risk Management
Drug Development
Formulation Development
Strategy Development
Business Development
Chemical Engineering
Clinical Trials
Cmc
Commercialization
Biopharmaceuticals
Drug Delivery
Clinical Development
Change Control
Capa
Process Development
Cgmp
Kevin Bittorf Education Details
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University Of AlbertaChemical Engineering -
University Of AlbertaMba
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University Of AlbertaChemical Engineering
Frequently Asked Questions about Kevin Bittorf
What company does Kevin Bittorf work for?
Kevin Bittorf works for Scxcmc
What is Kevin Bittorf's role at the current company?
Kevin Bittorf's current role is Founder and Principal Consultant @ SCxCMC | Pharmaceutical Consulting.
What is Kevin Bittorf's email address?
Kevin Bittorf's email address is ke****@****rtx.com
What is Kevin Bittorf's direct phone number?
Kevin Bittorf's direct phone number is +161794*****
What schools did Kevin Bittorf attend?
Kevin Bittorf attended University Of Alberta, University Of Alberta, University Of Alberta.
What are some of Kevin Bittorf's interests?
Kevin Bittorf has interest in Collecting Antiques, Exercise, Electronics, Outdoors, Home Improvement, Reading, Music, Sports, The Arts, Movies.
What skills is Kevin Bittorf known for?
Kevin Bittorf has skills like Gmp, Formulation, Quality By Design, Design Of Experiments, Cross Functional Team Leadership, Contract Manufacturing, Ind, Fda, Biotechnology, Regulatory Filings, Risk Management, Drug Development.
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