Description
Consultant, Project Manager Capital Projects, PharmaceuticalSummary Our client, a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago is seeking a Project Manager to support the ongoing Capital Projects portfolio at their GMP site in an operational readiness program to prepare for Drug Manufacturing/Phase III Product Development.
Duties / Expectations of Role · Facilitate small to large complex projects with teams composed of cross-functional and geographically dispersed members
· Provide leadership and direction to assigned project teams through application of expertise in project management tools and processes.
· Institute comprehensive work breakdown structures for all team deliverables; track and follow up on implementation of team decisions.
· Ensure high levels of communication with project teams, support resources and management.
· Identify resource and schedule constraints, key risks and issues to be resolved, and proactively drive the development of contingency and/or risk mitigation plans.
· Support the coordination and cascading of plant operations key performance indicators; maintain and report applicable department metrics.
· Develop, implement, and manage an effective standardized approach to program/project management with regards to compliance with company standards, schedule milestones, resources, and costs (including capital and operational).
· Participate in designing and continuously improving PMO project tools and processes
Mandatory Requirements · 3+ years in biopharmaceuticals or highly regulated industry
· 2+ years of project management experience
· Ability to navigate GMP manufacturing areas; knowledge in all GMP to comply with CFRs and ICH Q7
· Experience in varied and progressively challenging operations roles with the biopharmaceutical/pharmaceutical industry and possess a strong knowledge of GMP manufacturing, quality and/or regulatory processes and challenges.
· Expertise in operations management, CMC Management, Program management of rapid startup activities for facilities, New Product Introductions and Planning, Product Tech Transfer domestic or global, FDA inspection management
Term & Start · 6-12 month contract
· Onsite in Maryland
