Project Manager 2 - Process Engineering

About the role

Located in Raritan, NJ, this 12‑month contract position is for a Senior Material Excellence Engineer, Site MSAT. The role leads global implementation of dual sourcing of Lentivirus materials for Project S.U.R.G.E (Single Use Resiliency & Growth Evolution), driving reliability, innovation, and sustainability across internal and external processes and plants. It requires facilitating change activities within a global network, collaborating with internal and external partners, and working cross‑functionally with strong communication skills to ensure program success. Up‑to‑date knowledge of industry standards, regulatory requirements, and pharmaceutical manufacturing processes related to viral manufacturing and/or cellular therapies is highly desirable.

Responsibilities

• Identify and lead process improvement projects, specifically dual sourcing of materials utilized in lentivirus manufacturing, to deliver innovations and increase reliability of 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 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.
• 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.

Requirements

• 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.
• A minimum of a bachelor’s degree is required; a Bachelor’s in Biochemistry, Biotechnology, Chemical Engineering, or a related field is preferred.
• Fluent in written and spoken English.

Skills

• Strong expertise in biological manufacturing processes, including upstream and downstream processing.
• Familiarity with material specifications, URSs, and change controls.
• 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 and Excel.
• 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.

Pay

Pay Range: $48/hr – $51.10/hr