Sr Project Mgr - AFP
Thousand Oaks, California | Contract
Our client develops differentiated, innovative medicines that meet important unmet medical needs.
We are looking for a Sr. Project Manager (SPM) who will independently manage planning and execution of Process Development (PD) projects which are in the company' s late stage development phase, between E2L and commercial launch.
These PD projects may include the development of Drug Substance (DS) processes, Drug Product (DP) processes, analytical test methods, and/or combination products.
The SPM will work closely with team members from all functions within PD to ensure the project is executed in compliance with company procedures and completed on time within the resource constraints.
The position requires vertical and horizontal communication across many levels and functions inside and outside of PD. Depending on the assigned project the SPM might work with Global Operations Leads, Regulatory Leads, Product Quality Leads, Product Delivery Teams, and other stakeholders.
The SPM will be responsible for scheduling and moderating cross-functional team meetings. The SPM will create meeting minutes which are frequently distributed all the way to SVP level management.
Depending on the assigned project the SPM might also:
- lead the preparation, moderation, and documentation of various governance review meetings with Senior PD Management such as DS Technical Reviews, DP Technical Reviews, PD Portfolio Reviews, and/or Design Control Board meetings.
- author the Design and Development Plan and the DHF index for combination products.
- leverage PM tools to provide guidance to project teams in identifying the best approaches to complete projects on time, to overcome obstacles, or to react to scope or timeline changes.
- travel to other facilities or external partners as needed.
The focus of the SPM will be to:
- develop and maintain realistic and dependable project schedules together with project teams
- support the project teams in executing the projects by establishing the necessary teamwork tools (e.g. project sites and team folders on MyTeams / Box or other network drives)
- establish and maintain project controls and pro-actively monitor project progress
- provide guidance to project teams how to keep their deliverables on schedule
- provide PD Senior Leadership Team frequent project status updates via meeting minutes
- Hands-on Project Management experience with the development and/or manufacturing of drug substance and/or drug product for (bio) pharmaceuticals
- excellent verbal and written communication skills
- strong analytical, critical thinking, and problem solving skills
- strong MS Project and MS Office skills
- strong interpersonal skills