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.
