Seasoned professional with proven success in developing organizations through resource development, strategic planning and building collaborative cross functional teams designed at delivering targeted objectives. Specific areas of focus include; medical device, scaling manufacturing operations, international and domestic trade compliance, revenue operations, implementing focus on customer experience and regulatory compliance.

Entrepreneur & Pioneer. Drug hunter: 40 drugs in clinical development, Neurology/Psychiatry, HRT and Cancer, 3 marketed. 14 y in Biotech. 23y in Pharma, 6y in Academia. Business streamlining and negotiation of strategic and financial agreements.

Optimized communication for individuals and teams including executive leadership for improved outcomes in workflow and bottom line. Talent Integration, Pitch Team Coaching, , Strategic Alignment of Team within Organization, Leadership Development, Communication Intelligence, Creative Mindset, Reorganization, Onboarding, Board Engagement, Talent Retention, Equitable Meetings, Assessment.

Experienced Board Member, CEO and senior executive with proven ability to build, develop and grow international businesses. A highly strategic and results focused visionary leader for building and developing early stage, turn-around, and established companies. Repeated success in leading early stage and established companies to the next level of growth and expansion. Extensive and diverse experience that provides valuable perspectives and insights to Boards and corporate management across the company in setting vision, focus, goals, and strategies that produce the best possible results. Balancing drive and passion for growth with fiscal responsibility while generating the highest possible ROI.

Experienced drug discovery professional, medicinal/organic chemistry, pharmaceutical/agricultural/personal care chemistry, discovery CRO management, lab operations, IP expert, technology transfer assessment & due diligence, site start-up

Providing supply chain and clinical distribution support to early-stage and venture-funded biotechnology and pharmaceutical companies:
- Drug product fill/finish.
- Drug product packaging and labeling.
- Drug product and ancillary inventory management.
- Clinical supply distribution.
- IRT management.

A full-service international consulting and product management firm that provides CMC development, manufacturing, regulatory affairs, launch, and operational support to pharmaceutical and biotech companies.​

Cintas Cleanrooms use a highly specialized laundering process with strict standard operating procedures and stringent requirements that meet and maintain ISO 9001 certification. We provide gowning services and cleanroom supplies to ensure that your facility is functioning at peak performance.

Quality Assurance and Compliance; GCP/GLP/GCLP/GMP/CSV/Part 11; Training, auditing, SOPs; drugs, devices, biologics, dietary supplements

1. Provide three distinct professional services: Enable – Establish a culture of excellence to build in quality and avoid the costs of poor quality; Solve – Provide problem solving expertise and applying over 30 years of practical experiences to solve the organizations most critical issues; and Enable – Equip an organization’s employees through training and development.
2. Fractional or Permanent leadership role in Quality, Continuous Improvement, or Transformation leadership.

Competencies:
LEAN, Six SIgma, Continuous Improvement, Process Design, Product Development, Risk-based Quality Management, Customer Quality, QA, QC, Regulated Industries, Global Standards, Medical Devices, GMP, Life Sciences, Operations, Manufacturing, Product Services,