Job Description :
Notes:
Red Flags: No IS/IT Project Managers. No Automotive Industry Project Managers. No Aerospace Project Managers. No Construction Project Manager.
Interview Process: Phone screen followed by a face to face interview.
Description:
Responsible for integrating Process Development activities by developing and maintaining project schedules for Client pipeline and biosimilar projects.
The PM will partner with PD functional leads to identify key deliverables and will ensure cross functional alignment and accountability.
Work with the Global Operations Team and technical leaders in Process Development to create project schedules that align with MIWO prioritization.
Assist PD in driving decision making using DAI principles. Ensure participation in functional and cross-functional management reviews.
Establish and manage collaboration and team sites (e.g. My Teams Manage and prioritize support of multiple teams at one time.
Provide meeting facilitation, including development of meeting agenda and minutes. Accurately capture and monitoring status of action items through effective tracking tools and communication of progress.
Communicate as a Process Team and Global Business Team representative to individuals and groups, both at ACO as well as Companywide.
Track delivery and create repositories for all PD deliverables (Tech Reports Partner with Business Analysis and Performance to report product metrics.
Facilitate and incorporate lessons learned, best practices, etc. Support Business Process improvements, including alignment with CMCX. Project reporting including appropriate risk analysis.
Requirements:
Doctorate degree & 2 years of Project Management experience OR Master’s degree & 3 years of Project Management experience OR Bachelor’s degree or & 5 years of Project Management experience OR Associate’s degree & 8 years of Project Management experience OR High school diploma / GED & 12 years of Project Management experience.
Design Controls experience. Biopharma experience. Communication and engagement skills.
Experience with MS Office, Project, Excel and SharePoint.
The PM needs to be comfortable with complexity and ambiguity to think strategically and see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and facilitate decision making.
Deep understanding of and experience with disciplined product development processes (phase/gate product development method
Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes.
Experienced in creating and maintaining a Design History File. Proven ability to manage in a highly fluid, interactive, matrixed environment.
Preferred Qualifications:
PMP Certification. Minimum of 5 years of experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC experience is highly desirable.
Ability to foster collaboration and work effectively on cross-functional teams.
Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization.
Critical thinking and problem solving skills. Apply standard Project Management tools, and practices.