Senior Project Manager - New Albany, United States - EPITEC
Description
Ideal candidate: supporting process development. needs to have a biotech, med device, pharmaceuticals wants them to bring 5 years of experience. Experience with GMP environment Technical degree preferred: Engineering open to chemical, mechanical, etc. Candidate should showcase they have executed projects took ownership full lifecycle. Ideally smart sheets, MS Project, or other PM tools.
As a member of the, Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI). NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.
The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.
Primary responsibilities include assessment of NPIs for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.
Work with various NPI support groups to develop, maintain, and execute the NPI project plan and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and escalation to various levels of management as appropriate.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Manage change control and coordinate with various functions to ensure success initiation, execution, and implementation of the change records.
Familiar with project management tools (Smartsheet preferred) and proven records of successfully leading multiple projects at the same time.
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
*NO C2C. W2 Contract ONLY.