Senior Material Excellence Engineer, Site MSAT

o 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. o 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.

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

DESCRIPTION:
POSITION SUMMARY:
o 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.
o 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.
o This role will work in a cross functional setting and must have strong communication skills to foster collaboration and drive success across the organization.
o 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
o 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.
o 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.
o 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.
o Implement standard processes for supply chain management, logistics, and distribution to enhance operational effectiveness.
o Work closely with the production and manufacturing teams to optimize resource utilization and reduce costs.
o Drive organizational change by implementing effective project management strategies and communication plans.
o Effectively delegate tasks and provide clear direction to ensure smooth and efficient project execution.
o Continuously monitor/analyze manufacturing performance and design projects/initiatives to enable manufacturing performance, cost reduction, and process robustness objectives
o Conduct risk analysis to identify mitigation opportunities.
o Generate custom visuals and analytics detailing critical path, key handoffs/transitions & high-level summary schedule.
Collaboration & Communication:
o Collaborate effectively with local and global stakeholders, including project teams, site and global Leadership teams, ensuring seamless integration and communication of project requirements.
o Represent the Site MSAT group at internal and external meetings, effectively communicating manufacturing requirements and insights.


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

Technical Skills:
o Strong expertise in biological manufacturing processes, including upstream and downstream processing.
o Familiarity with material specifications, URSs, and change controls

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

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

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

LANGUAGES:
o Fluent in written and spoken English.