Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

PREFERRED QUALIFICATIONS:

• Experience coming from the pharmaceutical manufacturing industry.
• Knowledge of Computer System Validation (CSV) in the pharmaceutical manufacturing industry.

DISCLAIMER

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Required Qualifications:

• 5+ years of IT Project Management experience.
• Preferable to have worked in pharmaceuticals or life sciences
• First-hand experience running infrastructure projects (data center buildouts, infrastructure installation, migrations).
• Experience working inside an enterprise PMO.
• Knowledge of project management processes, such as Scrum and Agile.
• Strong communicator and ability to manage/lead diverse teams.
• Successful candidates will typically possess a bachelor’s degree in a technical discipline.
• Project Management designations such as PMI, SCRUM Master
• Computer proficiency in Microsoft Project, Word, Excel and Outlook and the ability to utilize enterprise software tools

THIS ROLE:

Simtra BioPharma Solutions is seeking an experienced IT Project Manager to lead infrastructure and enterprise technology initiatives that support our mission of delivering high-quality sterile injectable medicines. This hybrid role based in Parsippany, NJ requires a collaborative leader with strong project management skills, pharmaceutical industry experience, and a passion for driving operational excellence.

THE RESPONSIBILITIES:

• Lead complex technology projects (several simultaneously) from project planning through go-live
• Ensure project and resource plans are created, managed, and maintained
• Ensure project objectives are achieved
• Manage project change orders as appropriate
• Ensure PMO processes are followed in accordance with policy
• Hire, oversee and provide guidance to project staff.
• Manage technology project subcontractors and vendor relationships on projects
• Lead weekly project meetings ensuring that all relevant project updates/data are shared with stakeholders and IT leadership.
• Proactively manage risks and potential blockers and implement corrective measures.
• Work with finance and sourcing teams to manage contracts, invoices, etc. and ensure the PMO reflects timely and relevant financial information.
• Collaborate with the support organization to ensure that projects are properly handed over post implementation and ensure successful transition to the support teams.

Required Qualifications:

• 5+ years of IT Project Management experience.
• Preferable to have worked in pharmaceuticals or life sciences
• First-hand experience running infrastructure projects (data center buildouts, infrastructure installation, migrations).
• Experience working inside an enterprise PMO.
• Knowledge of project management processes, such as Scrum and Agile.
• Strong communicator and ability to manage/lead diverse teams.
• Successful candidates will typically possess a bachelor’s degree in a technical discipline.
• Project Management designations such as PMI, SCRUM Master
• Computer proficiency in Microsoft Project, Word, Excel and Outlook and the ability to utilize enterprise software tools.