Position Details:
- Role: Project Manager - Within the Manufacturing team
- Assignment Length: 6 months
- Location: 100% onsite at RTP, Raleigh, NC
- Schedule: Mon - Fri, standard work weeks and hours with occasional overtime as needed.
Overview: This position will support the Large-Scale Manufacturing (LSM) Modernization project for bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area. This system will encompass several phases covering electronic equipment tracking, electronic batch records and release by exception functionalities. This role will be supporting the operational readiness workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations. Job Summary: The Operational Readiness Project Management role will provide support to the Operational Readiness Program Manager for assisting in daily activities related to the internal large-scale manufacturing (LSM) modernization project bringing MES and electronic batch record implementation to the site. This role will work with a cross-functional matrix team including members from MTO, QA, QE, Materials Planning, Manufacturing among other groups as it relates to interactions with design and implementation of MES functionality. This role will be responsible for leading meetings, capturing meeting minutes, identifying and tracking action items, development of risk registers and mitigations and driving the team for adherence to plan. This role will provide schedule development support as well and act as a point of contact for routine schedule updates. Responsibility for tracking operational readiness action items, development plans to support approach, and providing monthly status dashboards. This role will have no budgetary responsibilities. Information will be communicated up to Operational Readiness Program Lead as well as Project Program Manager. Working Conditions:
- This position will be based on-site at an operational pharmaceutical facility in Raleigh, NC
- Mon - Fri, standard work weeks and hours with occasional overtime as needed.
- Regular interaction with project teams, contractors, and site operations staff will be required.
- Ability to work in an open office environment with frequent distractions.
- Ability to work within a matrix team is required.
Duration / Location:
- Position will initially be for a 6-month contract with a possibility of extension dependent on project needs and colleague performance
- Position will be located at the Biogen facility in Raleigh, NC
- Position requires on-site presence, 5x days per week
Minimum Education Requirements:
- Bachelor's degree in engineering, science, project management or other technical field of study
Minimum Experience Requirements: Proven success leading projects or acting in a project management support capacity with 10 or more years of experience • Familiarity utilizing Project Management Tools based on PMBOK, PMI principles to lead projects • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional, matrixed teams. • Experience leading or supporting operational readiness elements of projects • Organized, and detail-oriented with ability to manage multiple tasks simultaneously in a fast-paced environment. • Demonstrated ability to work within a highly regulated, compliance-driven setting (pharmaceutical industry). • Experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects is desired • Proficiency with MS Office suite of products and other software platforms • Proficiency in MS Project, Smartsheet, Primavera P6 or other project management software • Proficiency in project portfolio management software is a plus
