Service
Specialties

The scope of CMC product development is well established: develop, transfer and implement GxP compliance manufacturing processes and analytical methods to support compliance clinical product supply and eventual marketing authorization. What differentiates the truly exceptional programs are those that accomplish this with speed, efficiency, cost-effectiveness and reliability. My goal is to help sponsors assess their needs, explore opportunities and move with clarity, transparency and decisiveness. Together, we will manage risks, make informed decisions and hold key suppliers accountable for delivery. Along the way, we will build a strong, productive and motivated cross-functional team that maintains internal and external alignment at all levels.

​Project management is often underutilized in the early stages of drug development. While keeping timelines and action items are critical to success, the exceptional PM also builds and maintains team cohesion, identifies and resolves risks, communicates transparently and provides relentless focus on team performance and accountability. Together, we will build a program or project from the ground up if necessary and then develop a strong working team to manage the project with consistency and quality. Stakeholders include executive management, 3rd party partners and regulatory agencies; our project will incorporate their needs and expectations into the ways of working to ensure we maintain alignment with the business strategy and company culture.

My leadership experience spans a range of teams; from supervising the manufacturing swing shift to SVP on the executive team, I have had the privilege of leading and being part of high performing teams throughout my career. My goal is to help optimize the working relationships and productivity of teams of any size, at any level within the organization. Of particular focus is helping teams navigate the new reality of remote work. Together, we will identify the specific cultural norms and expectations of your team to allow the creation of tools and guidelines to help people do their best work in remote and hybrid workplaces.

I will be evaluate your facility or those of your current and future partners to assess their technical capabilities, GxP compliance and readiness for regulatory scrutiny (i.e. PAI preparation). If you are evaluating your CDMO options, my site visits can help you make the right decision, one that balances technical proficiency, compliance, cost-effectiveness and project execution capabilities.