Executive Leadership

Our team is comprised of experienced leaders who have successfully built and
managed growing, global businesses. From early-stage private to Fortune 500 listed companies,
our team has exceptional depth of leadership experience in pharmaceutical development,
manufacturing, and commercialization.

  • Healthcare Executive with extensive experience providing strategic and operational leadership for both large public corporations and private growth-stage companies
  • Deep domain expertise in sterile injectable pharmaceutical development, manufacturing, and commercialization
  • Expert at building high performing teams; advocate for patient safety, scientific discovery, and healthcare innovation
  • Accomplished leader with over 25 years of experience driving profitable growth through process transformation and strategic planning
  • Expert in M&A integration, risk management, financial controls, financial restructuring, and infrastructure/manufacturing process implementation
  • Skilled in leading all finance functions for both private growth-stage companies as well as multi-level, matrixed organizations
  • Experienced Quality executive skilled in Pharmaceutical Development, Quality Management Systems, Validation, Quality Control and Regulatory Affairs
  • Extensive experience leading teams to successfully develop regulatory submissions for Medical Devices, Drug Products, Biologics, and Combination Products
  • Certified Quality Engineer, Regulatory Affairs Certification, Master of Business Administration
  • Expert builder of corporate and product brands with proven track record in the pharmaceutical, biotechnology, and healthcare industries
  • Specializes in innovative go-to-market strategies and creation of differentiated value propositions to drive market adoption
  • Leverages creative agency leadership experience to deliver innovative marketing programs with measurable impact
  • Operations leader with extensive experience in manufacturing operations, engineering, and facilities management in the CDMO market segment
  • Specific expertise in building, staffing, and managing multiple cGMP manufacturing facilities across the United States
  • Trained as a mechanical engineer and earned an advanced degree in management of technology
  • Executive leader with over 30 years in the CDMO space for aseptic manufacturing of sterile injectable products for global markets
  • Extensive experience in aseptic manufacturing, including process development/optimization, small-scale clinical trial material, scale up, and large-scale commercial supply
  • Specific expertise in microbiology, validation, process design, technical transfer, form/fill/finish, and global strategy, all related to aseptic manufacturing of liquid and lyophilized parenteral drug products
  • Transformational leader with over 30 years’ experience driving Supply Chain excellence across all global supply chain functions. 20+ years specifically supporting Pharmaceutical, Biotechnology, and Healthcare industries
  • Extensive experience executing strategic initiatives from inception to conclusion, leveraging customer insights and broad Supply Chain expertise to unlock both customer and shareholder value
  • Specific expertise in Sales and Operation Planning, Distribution and Logistics, Global Trade Compliance, Controlled Substance Compliance, and Production Planning and Inventory Control
  • Expert counsel with extensive experience handling all legal functions for start-up and early-stage pharmaceutical companies
  • Skilled litigator, negotiator, and manager of contracts, licenses, non-disclosure, and commercial agreements, including intellectual property
  • Licensed in Tennessee and California
  • Exemplary track record in project management with expertise in executing complex projects
  • Foundational scientist, passionate about solving complex problems and leading cross-functional teams
  • Collaborative leader, highly skilled at managing change and creating innovative solutions for clients

Senior Leadership

From lab to launch, our team has formulation, testing and regulatory pathway expertise that can help successfully guide your project through every development and manufacturing milestone. Collective expertise, responsiveness, and accessibility sets the August Bio team apart.

  • Innovator and Generic drug launch experience
  • Trained bench chemist, experienced leader in Quality/Operations, guiding clients from development to market
  • Unique customer-centric perspective having worked on both sides (as innovator and CDMO)
  • Exceptional quality leader with wide-ranging experience as a bench scientist, managing supervisor, and site lead overseeing laboratories for big pharma and CDMOs
  • Strong track record with regulatory agencies and deep expertise with Chemistry, Corrective and Preventive Action (CAPA), and Good Laboratory Practice (GLP)
  • Certified Lean Sigma Greenbelt
  • Extensive experience in large and small volume parenteral manufacturing facility startup, commissioning, qualification activities, process optimization, and quality compliance
  • Skilled in the design, development, and validation of cleaning, sterilization, and aseptic process simulation programs
  • Expertise in microbiology, validation, aseptic manufacturing process, and six sigma process improvements