Senior Scientist MSAT

Kelly, in partnership with Johnson & Johnson, is hiring a Senior Scientist MSAT

Description:

The Senior Scientist MSAT is responsible for leading the global implementation of dual sourcing for Lentivirus materials, specifically for Project S.U.R.G.E (Single Use Resiliency & Growth Evolution). This project aims to drive reliability, innovation, and sustainability in our processes and plants worldwide, both internally and externally. The ability to effectively facilitate change—including navigating within a global network and collaborating with internal and external partners—is key to driving critical programs to successful completion.

This role will operate in a cross‑functional setting and must possess 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 is highly desirable.

• Identify and lead process improvement 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 the 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 assessments, determination of material quality attributes, and 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 and analyze manufacturing performance, and design projects and 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, and high‑level summary schedules.
• Collaborate effectively with local and global stakeholders, including project teams and 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.

Bachelor’s degree. Biochemistry, Biotechnology, Chemical Engineering, or a related field is preferred.

Minimum of 5 years of experience in the pharmaceutical or biotechnology industry.

In‑depth working knowledge and familiarity with cGMP guidelines and Health Authority regulations (EMA, FDA, etc.).

Strong expertise in biological manufacturing processes, including upstream and downstream processing.

Familiarity with material specifications, URSs, and change controls.

Demonstrated expertise in MS Project.

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.

Demonstrated ability to solve complex technical challenges independently and in a team setting.

Specific advanced therapies or lentiviral vector experience.

Experience working in a global matrix organization.