MSAT Project Manager

Lancesoft; Raritan (NJ); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Lancesoft seeks a Senior Material Excellence Engineer, Site MSAT, in Raritan, NJ. Hybrid role (3 days onsite) focusing on lentivirus material dual sourcing and process development for global manufacturing. Strong PM, R&D, and regulatory awareness are essential.

The candidate will lead cross-functional initiatives, manage vendor interfaces, and ensure compliance with cGMP and change controls while driving reliability and cost improvements across sites.

Qualifications

• Bachelor's degree required in relevant field.
• 5+ years pharmaceutical/biotech experience required.
• 3+ years of project management experience required.
• Upstream and/or downstream knowledge preferred.
• R&D and Process Development background required.

Responsibilities

• Identify and lead dual sourcing projects for LV materials; manage project plans.
• Create URS, review vendor drawings, perform comparability assessments, and manage change controls.
• Implement supply chain, logistics and distribution processes to improve efficiency.
• Collaborate with production teams to optimize resources and reduce costs.
• Drive change management and effective communication across global stakeholders.
• Develop analytics showing critical paths and milestones.

Skills

Project management

Process development

Biopharma manufacturing

Change control

Communication

Education

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

Tools

MS Project

PowerPoint

Excel

Job description

Role: Senior Material Excellence Engineer, Site MSAT Location: Raritan NJ 08869 Duration: 10/05/2026 to 10/04/2027 Message Body:

Notes from Manager:

• - Role will be HYBRID (3 days onsite) in Raritan, NJ office
• - Bachelors degree is required
• - Must have at least 5 years of Pharma/Biotech background/exp
• - Must have at least 3 years of Project Management exp
• - Knowledge with Upstream and/or Downstream is highly preferred
• - Research and Development is REQUIRED
• - Must have Process Development background exp
• - Should have a background in lentivirus manufacturing
• - This role is LESS procurement, and MORE of a Process Development role
• - Experience with COMET and/or TruVault
• - Must be familiar with Change Control Mgmt Systems

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: Minimum of 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. Familiarity with material specifications, URSs, and change controls 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.