Helping BioPharma clients achieve their goals and more
I provide program management, project management and project leadership for clients at critical stages.
CMC Programs
Technology Transfer
Quality Systems Management
Compliance Remediation / Audit Response
Facility Start Up, Commissioning, Validation and Qualification
Project Management enables team members to focus on the right tasks at the right time.
Project Leadership inspires higher performance and enables project teams to become more than the sum of their parts. High performing project teams support project success in the near term and also deliver long term benefits to the organization.
My approach has been developed and honed over 20+ years in the industry.
Call, email or use the contact form to tell me about your unique needs.
“It was a pleasure to have worked with you. You were an instrumental part of the team, and without your contributions, we would not have progressed as far as we did. I hope that we get another opportunity to work together.”
Areas of Expertise
CMC
Clinical and commercial stage CMC team members need to focus on tactical matters without losing site of both near-term and long-term strategy. Program management support allows your CMC technical lead to remain above the fray and lead. Leadership support allows CMC teams to function at a higher level to develop time saving strategies and deliver on strategic goals.
Compliance
Audit response, gap analyses, risk assessments and compliance remediation projects require an ability to lead and motivate teams of experts. These projects are typically not directly linked to production and release of batches. Many teams struggle to secure the resources and engagement necessary despite high stakes for the organization’s reputation and compliance position. Successful leadership on such projects is characterized by flexibility while employing the right touch to secure and maintain sufficient resource engagement to remain on track.
Technology transfer
Technology Transfer projects place almost impossible demands on an organization. Teams must support aggressive targets for start of clinical or commercial production while ensuring that a complex process is transferred with no detail overlooked. Technology Transfer teams must be high functioning, intelligent and highly adaptive. Project management allows team members to focus on execution. Project leadership is needed for teams to function at the level required for successful technology transfer.
Facility Start-up, Commissioning, Qualification & Validation
Planning, resources and schedule adherence are key so a crisp, focused and driven project management style is called for in Start-Up and CQV projects. With the right execution partners a talented planner and project manager can find the most efficient path to success. While CQV projects are highly tactical, open communication and teamwork support better planning and foster greater engagement.
Quality Systems
Owners of Quality System records may not think of themselves as project managers but they are. Efficient resolution of Change Controls, Investigations, and CAPAs requires project management and leadership skills to plan, manage scope, secure resources, lead a team in execution and effectively communicate status within the organization.
Project Planning & Execution
Every successful project includes a mix of key ingredients including planning, scope definition, communication, resource engagement, team motivation, and leadership. There is no “one size fits all” mode of project management. The mix and magnitude of project management tools application is different for each project and may change during the project’s life cycle. A project manager who can wear the planner hat, quickly change to the manager hat and also lead to motivate a team to higher performance is a valuable addition to any organization.