Pharmaceutical Manufacuring Project Manager

Are you a Project Manager with experience supporting Pharmaceutical Manufacturing and MFG / MES systems?

We are looking for a candidate with biopharmaceutical manufacturing experience to join our team.

This is a W2 contract. Please no C2C assistance is needed at this time.

Working knowledge and understanding of manufacturing applications, GxP/GMP and Application System Validation procedures in a regulatory manufacturing environment will be important and needed for this role.

Must be knowledgeable in biopharmaceutical manufacturing execution systems (MES), SCADA, and have working knowledge of Finite Scheduling efficiencies (i.e. all jobs can be completed with the available resources, including labor, machinery, and materials.) Important candidate has the experience in planning schedules with tasks, activities, and must be proficient in status reporting, risk/issue mitigation delivered and completed on time and within budget.

PM will be responsible for all budgeting (itemized CAPEX line items), forecasting, PO’s, Invoices and is expected to provide status of project invoices and shipment / receiving of equipment. Will provide planning and provide guidance re: how the work will be done and will align and work closely with the Product Owner.

Tasks include are as follows:

Establish comprehensive initiative and objective/scope understanding.

Create and maintain Project Charters/Vision Statements for each workstreams

Create and maintain Project Plans

Create and maintain Project Schedules

Create Status Reports

Document Control - Manage Document Repository Folders

Budget Management (PO’s, Invoices, Forecasts)

Communication Plans

Create, maintain and distribute Meeting Minutes to team and stakeholder members

Schedule meetings with Agenda Items and Expectations of the meeting

Create and maintain RAID Logs

Must Have’s

Excellent communication and organizational skills

Program Management/Sr. Project Management Experience managing multiple workstreams and teams

Experience working within Agile methodology

Smartsheet experience

Jira experience

Meeting facilitation and ownership experience

Critical Thinking skills

Leadership experience managing projects in a regulatory manufacturing environment

Drive, follow up

Risk, Issue identification, reporting and mitigation to closure

Candidate should be curious. Dig in and investigate. Initiative to understand the domain and technologies.

Background in engineering or technical (coding) a HUGE PLUS

Experience with AI/ML a HUGE PLUS

Tools: Smartsheet, Jira, Miro, MS Office 365, MS Teams, Confluence, SharePoint, Teams Meeting

Prefer candidates local to New Albany, OH or willing to travel at least once a month onsite for 3+ days.