Process Scientist - MSAT (Hybrid role)

Description:

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

GENERAL RESPONSIBILITIES:

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.

KEY QUALIFICATIONS & SKILLS:

Experience:

• Minimum of 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

Technical Skills:

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

Certifications and Software Proficiencies:

• 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, Excel, required.

Interpersonal Skills:

• 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.

DEGREE:

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