Piper Companies is looking for a Project Manager-Process, Validation, & Qualification in Summit, NJ to join a cutting edge biotechnology company focusing on cancer cell therapy research.
The Project Manager will execute projects in support of Process Validation and Process Qualifications of multiple products within a new building expansion.
- Lead key project meetings. Take meeting minutes. Monitor and track activities.
- Create project plans, define resources needed etc.
- Manage facility readiness, process mapping, perform risk assessment, ensure qualification of equipment – IQ, OQ and readiness for PQ.
- Communicate across functional areas – tech transfer, manufacturing, quality etc. – to ensure aligned on project timelines and deliverables.
- Summarize project status in a clear and concise message.
- Analyze information promptly, find root cause, triage any issues and implement remedy (or proposed solutions).
- Technical Project Management experience within CAR-T or Biologics experience is ideal. Pharma/small molecule exp OK – depends on how adaptable.
- Commercial Operations experience is key, not just CMC. *Could also come from a QA/QC background, but looking for commercial ops and strong ability to manage projects.
- Strong communicator, open to give and receive feedback, free-flowing exchange of ideas.
- Great attitude – the stress level is high with a 21-day manufacturing cycle time. Be able to react to critically in a comprehensive way, diffuse any misunderstanding in a productive way.
- Positive, high-energy, strong sense of keeping people motivated in a positive way.
- Familiarity with lean six sigma.
- Ability to work onsite in Summit 5 days/week.
Compensation for the Project Manager is commensurate to experience.
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org