at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Position Title: Commercial New Product Introduction (NPI) Project Manager
Location: Rockford - Assembly
Department: New Product Introduction
Reporting To: Global Director NPI
Responsible For (Staff): Yes
NPI Project Manager initiates, coordinates, and manages designated customer projects to ensure that both PCI and client are aligned for project success, establishing timeline, and orchestrating critical developmental steps and milestones to ensure successful commercialization within prescribed time frame and budget. Working with dedicated NPI team, NPI PM is the new project architect, designing and leading in integral activities to foster project success, providing PCI a competitive advantage in short term and long-term customer management through an industry leading customer experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Accountable for key New Product Introduction (NPI) project management activities by orchestrating and using appropriate project planning tools. Authors and defines program timeline and key milestones, communicates progress against milestones, drives critical path activities and assigns internal and external responsibility to ensure the project achieves all deliverables per the customer requirements and agreed upon project plan expectations.
In close partnership, support Customer Business Unit Project Manager as key point of customer contact for developmental activities, including timeline, budget and customer expectation management.
Provide support to business development as project scope changes occur and new business proposals are warranted to ensure accuracy.
Assist with Customer Supply Agreements/Contracts during project development.
Partner with internal technical team to ensure timely and effective solutions for packaging structural elements, impactful and compliant packaging graphics, as well as effective and efficient processes resulting in seamless startup.
Work with the customer to identify key elements of product launch and anticipated long term product needs, ensuring appropriate lifecycle solutions including efficient processes, appropriate capacity and line utilization including scalability, and solutions for product lifecycle requirements
Lead Project Team and Technical Kickoff Meetings for assigned projects, driving resolution for key decision points with key functional groups and internal/external stakeholders.
Assist with the establishment of technical specifications, batch records, trial protocols, and preparatory documentation in keeping with product/package and process development sequences. Advise and influence client on optimal solutions to ensure successful product introduction.
Provide and facilitate suggestions for packaging solutions in the areas of design and specification management.
Effectively facilitate a Lessons Learned review at the conclusion of project launch to ensure we capture best practices, receive constructive feedback, and develop solutions and action plans to make the next project a success.
Leverage deep understanding of MS Office software programs including Excel, Powerpoint, Project, Word, etc. as well as effective use of J.D. Edwards ERP to generate key project data and communicate critical aspects to key stakeholders.
Commit and meet budgetary objectives. Communicate adjustments and changes to project scope to PCI
lead team.
Establish effective meetings and communication plan to ensure success of each project.
Monitor and catalog new business awards. Analyze, project and forecast resource requirements as part of S&OP disciplines.
Manage customer visits to PCI.
Training and onboarding of new employees within same role, as requested.
This position may require overtime and/or weekend work. Position may require travel up to 25%.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
Special Demands:
Stationary Position: Under a 1/4 of the day.
Move, Traverse: From 1/4 to 1/2 of the day.
Operate, activate, use, prepare, inspect, or place: Up to 1/4 of... For full info follow application link.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
