Senior Material Excellence Engineer, Site MSAT

Lancesoft; Raritan (NJ); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Lancesoft seeks a Senior Material Excellence Engineer, Site MSAT, in Raritan, NJ, for a 12-month hybrid engagement. You will lead dual sourcing programs for lentivirus materials, coordinate with global teams, and ensure quality and regulatory compliance across projects.

Responsibilities include vendor assessments, change control, and process optimization to boost reliability and reduce costs in biopharma manufacturing.

Qualifications

• Requires around 5 years in pharma/biotech and cGMP familiarity.
• Experience with advanced therapies or lentiviral vectors is a plus.
• Strong communication and global collaboration capabilities.

Responsibilities

• Lead dual sourcing projects for LV materials to improve reliability.
• Manage detailed project plans for Project S.U.R.G.E and track deliverables.
• Create URS documents, review vendor drawings, perform comparability assessments.
• Manage change control processes and material quality attributes.
• Implement standard supply chain, logistics, and distribution processes.
• Collaborate with production to optimize resource utilization and reduce costs.
• Drive organizational change with effective PM strategies and communication plans.
• Delegate tasks and provide clear direction for project execution.
• Monitor manufacturing performance and drive cost reduction and robustness.

Skills

Project management

Communication

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Biochemistry/Biotechnology/Chemical Engineering or related field

Tools

MS Project

PowerPoint

Excel

Job description

Job title: Senior Material Excellence Engineer, Site MSAT Location: Raritan, NJ Hybrid Duration: 12 Months

DESCRIPTION

POSITION SUMMARY

• The Senior Material Excellence Engineer, Site MSAT is responsible for leading global implementation of dual sourcing of Lentivirus materials, specifically for Project S.U.R.G.E (Single Use Resiliency & Growth Evolution), that will drive reliability, innovation and sustainability in our processes and plants across the globe, both internally and externally.
• The capability to effectively facilitate change activities including the ability to navigate within a global network and collaborate effectively with internal and external partners will be key to drive critical programs to successful completion.
• This role will work in a cross functional setting and must have strong communication skills to foster collaboration and drive success across the organization.
• Up-to-date knowledge of industry standards, regulatory requirements and pharmaceutical manufacturing processes related to viral manufacturing and/or cellular therapies are highly desirable.

GENERAL RESPONSIBILITIES

Key Responsibilities

• Identify and lead process improvements projects, specifically dual sourcing of materials utilized in lentivirus manufacturing, to deliver innovations and increase the reliability of our processes and plants.
• Manage detailed project plans for dual sourcing of LV materials under Project S.U.R.G.E and collaborate with cross-functional team members to track deliverables, ensuring the highest standards of quality and compliance.
• Execute deliverables required for identification of vendors, including but not limited to, identification of materials for dual-sourcing, creation of URS documents, technical review and approval of vendor drawings, performance of formal comparability assessment, determination of material quality attributes, change control creation and implementation.
• Implement standard processes for supply chain management, logistics, and distribution to enhance operational effectiveness.
• Work closely with the production and manufacturing teams to optimize resource utilization and reduce costs.
• Drive organizational change by implementing effective project management strategies and communication plans.
• Effectively delegate tasks and provide clear direction to ensure smooth and efficient project execution.
• Continuously monitor/analyze manufacturing performance and design projects/initiatives to enable manufacturing performance, cost reduction, and process robustness objectives.
• Conduct risk analysis to identify mitigation opportunities.
• Generate custom visuals and analytics detailing critical path, key handoffs/transitions & high-level summary schedule.

Collaboration & Communication

• Collaborate effectively with local and global stakeholders, including project teams, site and global Leadership teams, ensuring seamless integration and communication of project requirements.
• Represent the Site MSAT group at internal and external meetings, effectively communicating manufacturing requirements and insights.

KEY QUALIFICATIONS & SKILLS

Experience

• Around 5 years of experience in the pharmaceutical or biotechnology industry is required.
• Specific advanced therapies or lentiviral vector experience is considered a distinct advantage.
• In depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA, FDA, etc.).
• Minimum of 3 years of project management experience.

Technical Skills

• Strong expertise in biological manufacturing processes, including upstream and downstream processing.

Certifications and Software Proficiencies

• Professional project management certification (i.E. PMP, CPM, etc.) is preferred.
• Demonstrated expertise in MS project is required.
• Proficiency with technology enabling tools including Powerpoint, Excel, required.

Interpersonal Skills

• Excellent communication and interpersonal skills, with the ability to build strong relationships with team members and stakeholders.
• Experience working in a global matrix organization is preferred.
• Demonstrated ability to solve complex technical challenges independently and within a team setting.

DEGREE

• A minimum of a bachelor s degree is required. A Bachelor s in Biochemistry, Biotechnology, Chemical Engineering, or a related field is preferred.

LANGUAGES

• Fluent in written and spoken English.