Job Title:

Senior Material Excellence Engineer, Site MSAT Location:

Raritan, NJ 12+

Months Contract Position Summary:

The Senior Material Excellence Engineer, Site MSAT will lead global implementation initiatives for the dual sourcing of Lentivirus (LV) materials under Project

S.U.R.G.E

(Single Use Resiliency & Growth Evolution) . This role drives operational reliability, innovation, and sustainability across internal and external global manufacturing facilities. Operating within a cross-functional and global matrix setting, this role requires strong project management capabilities, regulatory change-control expertise, and deep technical knowledge of pharmaceutical/biotech manufacturing processes related to viral vectors and cell therapies.

Key Responsibilities:

Dual Sourcing & Process Optimization:

Identify, scope, and lead dual-sourcing projects for critical single-use and raw materials utilized in lentivirus manufacturing to boost plant reliability and supply security.

Technical Vendor Execution:

Author User Requirement Specifications (URS), perform technical reviews of vendor engineering drawings, execute formal material comparability assessments, define critical material attributes, and initiate/close change controls.

Project Governance:

Build and maintain detailed schedules using MS Project, tracking critical path items, handoffs, key milestones, and high-level deliverables.

Supply Chain & Manufacturing Alignment:

Partner closely with production, supply chain, logistics, and MSAT teams to ensure material changes integrate smoothly without disrupting manufacturing operations.

Risk Management & Analytics:

Conduct structured risk assessments to proactively mitigate supply chain and manufacturing vulnerabilities; develop executive visuals, dashboards, and timeline analytics.

Cross-Functional Collaboration:

Act as the primary technical MSAT liaison across site leadership, global matrix teams, external suppliers, and quality assurance.

Qualifications & Requirements:

Education:

Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, or a related life sciences discipline.

Experience:

Minimum 5+ years of hands-on experience in the pharmaceutical or biotechnology sector. At least 3+ years of formal project management experience within a technical/manufacturing setting. Prior experience with lentiviral vectors (LVV) , viral manufacturing, single-use technologies (SUT), or cell & gene therapies is strongly preferred.

Technical & Regulatory Competencies:

Solid working knowledge of cGMP guidelines , FDA, and EMA regulatory standards. Experience with change control procedures , URS generation , material characterization, and tech transfers. Background in upstream and downstream biologics manufacturing workflows.

Tools & Software:

Advanced proficiency with MS Project , Excel, and PowerPoint. PMP, CPM, or equivalent project management certification is a plus. Thanks Sri Vardhan