Senior Material Excellence Engineer, Site MSAT
Location: Raritan, NJ
Pay Rate: $63.54/hour
Duration: 1 year
Job Description
- Lead global dual-sourcing initiatives for lentiviral vector (LV) manufacturing materials under Project S.U.R.G.E.
- Lead process improvement projects focused on material reliability, supply resilience, manufacturing performance, and cost reduction.
- Develop and manage project plans, milestones, deliverables, and critical-path schedules for material dual-sourcing programs.
- Identify materials and vendors and develop URS documentation to support vendor qualification and sourcing activities.
- Conduct technical reviews of vendor drawings and support formal material comparability assessments.
- Define material quality attributes and implement associated change controls.
- Analyze manufacturing performance and develop initiatives to improve process robustness and operational efficiency.
- Conduct risk assessments and develop appropriate mitigation strategies.
- Implement processes supporting supply chain, logistics, and material distribution.
- Develop project analytics, schedules, and visual management tools to track key handoffs and transitions.
- Coordinate site and global MSAT activities with manufacturing, production, supply chain, vendors, and leadership stakeholders.
- Support pharmaceutical manufacturing operations in compliance with cGMP and applicable health authority requirements.
Education
- Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related scientific/engineering discipline required.
Required Skills
- 5+ years of pharmaceutical or biotechnology industry experience.
- 3+ years of project management experience.
- Pharmaceutical/biotechnology manufacturing experience.
- Biological manufacturing processes, including upstream and downstream processing.
- Lentiviral vector or viral manufacturing knowledge.
- cGMP guidelines and pharmaceutical regulatory requirements, including FDA and EMA.
- Material specifications and quality attributes.
- User Requirements Specifications (URS).
- Change control development and implementation.
- Material comparability assessments.
- Vendor technical evaluation and qualification support.
- Manufacturing process improvement and process robustness.
- Risk assessment and mitigation.
- Supply chain, logistics, and material distribution processes.
- Microsoft Project.
- Microsoft Excel and PowerPoint.
Preferred Skills
- Advanced therapies or lentiviral vector manufacturing experience.
- Cell therapy manufacturing experience.
- Experience leading global material dual-sourcing programs.
- Experience in a global matrix pharmaceutical organization.
- PMP, CPM, or other professional project management certification.
- Experience with vendor drawings and technical specifications.
- Experience with manufacturing cost-reduction initiatives.
- Experience developing critical-path schedules and project analytics.