Please note this position is a 12 month contract position, and will be HYBRID (3 days onsite) in Raritan, NJ.
Please note this position requires Pharmaceutical/Biotechnology Industry Experience.
QUALIFICATIONS:
· Must have at least 5 years of pharmaceutical or biotechnology industry is required
· Must have at least 3 years of Project Management experience
· Bachelor’s degree is required
· Specific advanced therapies or lentiviral vector experience is considered a distinct advantage
· Knowledge with Upstream and/or Downstream is highly preferred
· Research and Development is REQUIRED
· Must have Process Development background experience
· 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 Management Systems
TECHNICAL SKILLS:
o Minimum of 3 years of project management experience
o in depth working knowledge and conversant with cGMP guidelines and Health Authority regulations (EMA, FDA, etc.)
o Strong expertise in biological manufacturing processes, including upstream and downstream processing.
o Familiarity with material specifications, URSs, and change controls
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.
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.
LANGUAGES:
Fluent in written and spoken English.
Job Description:
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
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.
Candidates must provide their phone number. Job reference code is A5553.
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