JD

The primary responsibilities for this role are to serve as Supplier Relationship Manager (SRM) for select Contract Manufacturing Organization (CMO) relationships and serve as project manager on designated projects.

Supplier Relationship Manager (SRM):
Accountable for the oversight and management of all business with the assigned Contract Manufacturing
Organization (CMOs).
Responsible for the relationship management and contract monitoring of active pharmaceutical ingredients (API) &
intermediates ,drug product, device assembly & packaging CMOs to ensure uninterrupted supply.

Project Manager (PM):
Accountable for the overall delivery of the project
Responsible for development, execution & monitoring of project schedule, budget, resources, communicating
risks/issues, developing & monitoring mitigations plans, and providing status updates as required.

Responsibilities:
Leads a cross-functional virtual plant team (VPT) in a matrix structure.
Promotes team development, fosters teamwork, and builds relationships within the VPT.
Drives performance and continuous improvement within the assigned CMOs to mitigate risks and optimize value.
Manages and maintains positive relations with the assigned CMOs through structured supplier relationship models
Develops and executes operational budgets for the assigned CMOs and ensures alignment with External
Manufacturing's goals and objectives.
Ensures the successful resolution of all issues that may impact timely supply of product and/or contractual
obligations
Effectively manages all operational activities to deliver supply from the CMOs. Contract Monitor for the assigned
business
Executes CMO specific strategies and processes in line with ExM Mission Statement.
Proactively identifies supply risks and implements strategies to avoid or minimize their impact
Accountable for the performance of the assigned CMOs.
Responsible for reviewing and communicating CMO performance metrics and the development of the
improvement plans as warranted.
Leads Business Review processes
Accountable for CMO' Business Continuity Risk Assessment
Ensures projects executed at the assigned CMOs are delivered in line with requirements
Collaborates with Finance for product cost standards, variances
Supports the transfer and launch of new products.
Develop detailed project timelines, resource plans, and charters
Leads a cross-functional project team(s) in a matrix structure.
Create and manage project budgets
Deliver on-time project execution
Identify & facilitate resolution of risks and roadblocks
Communicate program & project status
Achieve governance endorsements
Leverage standard project management tools (Tableau, Microsoft project, etc.) & align with established business
processes (charters, PMO, etc.)
Drive standardization of tools and templates to enable efficient and consistent tracking and reporting of projects in
line with best practices.


Designee Responsibilities:
This position can be a designee for Senior Director, External Manufacturing.

Required Competencies:
Operations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of
regulatory guidelines and validation practices.
Successful track record in execution and completion of objectives and projects.
Able to effectively transfer complex knowledge regarding science and engineering procedures.
Ability to apply technical and cross-functional expertise to address complex operations problems.
Analytical and creative problem-solving skills
Ability to lead teams and to work effectively with cross-functional & multi-location teams
Good inter-personal, communication, and presentation skills required.
Financial and project management skills
Experience of a culturally diverse workplace through international projects or global teams.
Experience negotiating supply agreements with CMOs.

Required Qualification(s) and Desired Experience:
BS/MS/PhD in engineering, chemistry, pharmacy or related pharmaceutical sciences.
MBA, C.P.M. and Project Management Certifications (i.e. PMP) desired.
8+ years of relevant experience in the pharmaceutical, biopharmaceutical or related industry