Senior MSAT Materials Project Lead

The Fountain Group; Raritan (NJ); On-site; USD 120,000 - 144,000; Full time

Job summary

The Fountain Group is seeking a Senior Material Excellence Engineer, Site MSAT in Raritan, NJ to lead global dual-sourcing for LV manufacturing materials and drive process improvements. You will manage programs, qualify vendors, and ensure cGMP compliance across sites, collaborating with manufacturing, supply chain, and leadership to deliver robust materials supply and cost efficiencies.

Requirements include a BS in a relevant discipline, 5+ years in pharma/biotech, and 3+ years of project

Qualifications

• Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related discipline.
• 5+ years of pharmaceutical or biotechnology industry experience.
• 3+ years of project management experience.
• Experience with viral manufacturing (lentiviral vector) is preferred.
• Familiarity with cGMP, FDA/EMA regulations, and change control processes.
• Knowledge of URS, vendor qualification, and material specifications.

Responsibilities

• Lead global dual-sourcing initiatives for LV manufacturing materials.
• Drive process improvement for material reliability and cost reduction.
• Develop and manage project plans, milestones, and schedules.
• Identify materials and vendors; prepare URS for qualification.
• Review vendor drawings; support material comparability assessments.
• Define material quality attributes and change controls.
• Analyze manufacturing performance to improve process robustness.
• Conduct risk assessments and mitigation strategies.
• Implement processes for supply chain, logistics, and distribution.
• Coordinate MSAT activities with stakeholders across sites.
• Ensure operations comply with cGMP and health authority requirements.

Skills

Pharma/biotech industry experience

Project management

GMP/regulatory knowledge

Vendor qualification support

Material sourcing

Risk assessment

Supply chain/process improvement

cGMP compliance

Process robustness

URS development

Lentiviral vector knowledge

Education

Bachelor's degree in Biochemistry / Biotechnology / Chemical Engineering

Job description

The Fountain Group is seeking a Senior Material Excellence Engineer, Site MSAT in Raritan, NJ to lead global dual-sourcing for LV manufacturing materials and drive process improvements. You will manage programs, qualify vendors, and ensure cGMP compliance across sites, collaborating with manufacturing, supply chain, and leadership to deliver robust materials supply and cost efficiencies.

Requirements include a BS in a relevant discipline, 5+ years in pharma/biotech, and 3+ years of project