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
  • 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
  • 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
  • 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
  • People and Talent expert with experience across companies of various industries, sizes, and stages
  • Extensive experience hiring and developing high-performing and engaged teams
  • Specific expertise in talent acquisition, performance management, compensation and benefits, learning and development, organizational design, and employee relations
  • 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
  • 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)
  • Experienced operations leader with expansive background focused on sterile injectable manufacturing
  • Extensive knowledge of operational excellence principles, including organizational learning, operational efficiency and performance management
  • Skilled in general and organic chemistry, operations management, team leadership, quality control, and lean manufacturing
  • Over 30 years of pharmaceutical experience with multiple leadership roles spanning Research and Development, Quality and Operations disciplines
  • Technical expertise in Analytical Development, Quality Control, Microbiology and Advanced Characterization Methods
  • Experienced in the clinical and commercial development of drug products, medical devices and combination products
  • 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
  • Engineering leader responsible for all aspects of engineering life cycle including equipment procurement through large-scale facility scale-ups
  • Responsible for 31 high volume and specialty product medical device manufacturing lines focused on capital investments and continuous improvements
  • Reliability centered facility optimization expertise based around TPM and loss elimination with a background in project / resource management and mechanical engineering
  • Accomplished Business Development Leader in the CDMO sector with a focus in sterile injectable manufacturing
  • Strong track record of driving growth, negotiating complex contracts, building long-term relationships and understanding client needs to deliver tailored manufacturing solutions
  • Expertise in leading cross-functional teams to enhance the client experience and ensure successful project execution
  • Passionate about driving innovation and excellence in sterile injectable manufacturing and supporting clients who are transforming human health
  • 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