R&D Process/Project Manager (Hybrid)(No Corp to Corp or H-1B)

Please note that this is a 12-month Contract position, Hybrid (3 days onsite) in Raritan, NJ. No Corp to Corp or H-1B.

JOB DESCRIPTION:

Top Skills:

A Bachelor's degree is required.

Candidates must have approximately 4 years of Pharmaceutical/Biotechnology experience and approximately 3 years of Project Management experience.

Research and Development (R&D) and Process Development experience are REQUIRED.

Experience with lentivirus manufacturing is required.

Knowledge of Upstream and/or Downstream Processing is highly preferred.

This role is more focused on Process Development than Procurement.

Experience with COMET and/or TruVault and familiarity with Change Control Management Systems are required.

Qualifications:

• Bachelor's degree required. Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field preferred.

• Approximately 4–5 years of experience in the Pharmaceutical or Biotechnology industry.

• Approximately 3 years of Project Management experience.

• Research and Development (R&D) experience is required.

• Process Development background and experience is required.

• Experience with Lentivirus Manufacturing is required.

• Knowledge of Upstream and/or Downstream Processing is highly preferred.

• Experience with Advanced Therapies or Lentiviral Vectors is a distinct advantage.

• Working knowledge of cGMP guidelines and Health Authority regulations, including EMA and FDA.

• Familiarity with Material Specifications, URS documents, and Change Controls.

• Experience with COMET and/or TruVault.

• Familiarity with Change Control Management Systems.

• Professional Project Management certification such as PMP or CPM is preferred.

• Excellent communication and interpersonal skills.

• Experience working in a global matrix organization is preferred.

• Ability to solve complex technical challenges independently and within a team setting.

• Fluent in written and spoken English.

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.

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.

Candidates must provide their phone number. Job reference number is A5576.