Role will be HYBRID (3 days onsite) in Raritan, NJ office

• Bachelors degree is required
• Pharma/Biotech background/exp
• Knowledge with Upstream and/or Downstream is highly preferred
• Research and Development is REQUIRED
• Must have Process Development background exp
• 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 Mgmt Systems

What hours will the contingent worker be expected to work? 8a - 4:30p EST

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.

KEY QUALIFICATIONS & SKILLS:

Experience:

• 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.)

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:

• Demonstrated expertise in MS project is required.
• Proficiency with technology enabling tools including Powerpoint, Excel, required.