Senior/Principal Engineer, CTTO Vector MS&T

Working with Us
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Position Summary:

Join the Cell Therapy Technical Operations (CTTO) division and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies.  The Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for a Senior/Principal Engineer to join our Viral Vector Commercial Network MS&T group. The key function of this role will be to provide commercial manufacturing support of our CMO GMP manufacturing facilities. Additionally, this position will be part of a team responsible for transferring commercial manufacturing processes and will play a key role in product lifecycle management including strategic development, validation, and approval of viral vector products. This person will collaborate cross-functionally to ensure project advancement, solutioning around challenges/opportunities, and rapid and best in class execution.

Key Responsibilities:

• Support all Manufacturing Sciences & Technologies (MSAT) activities at CMOs to ensure uninterrupted clinical/commercial vector manufacturing and supply
• Provide technical process support for routine clinical/commercial batches and assist QA with on time closure of all quality system records such as deviations, CAPAs and change controls
• Develop and manage tools/templates to monitor vector manufacturing process performance and enable understanding of process capability
• Implement and support the execution of process control strategies including execution of process risk assessments and CPV
• Ensure the manufacturing process is in a state of control through an understanding of CPV data
• Support production related investigations, determining the root cause and ensuring compliance with internal standards and regulatory requirements
• Support regulatory inspections and permanent inspection readiness
• Write technical reports in support of manufacturing process changes, deviation investigations and regulatory filings
• Develop and execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product
• Share operational best practices and process learning with the rest of the manufacturing network

Qualifications & Experience:

• Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with either a B.S. with a minimum of 6 years of relevant experience, a M.S with a minimum of 4 years of relevant experience, or a Ph.D. with a minimum of 2 years of relevant experience (Note: experience level will determine position title and enterprise grade level)
• Experience with technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support, and technology transfer
• Flexibility to work within manufacturing schedules and ability to travel frequently (50%)
• Experience with cellular therapies is preferred
• Ability to work in a self-driven, performance/results oriented, fast-paced matrix environment
• Demonstrated strong written and verbal communication, interpersonal skills, presentation skills, time management skills, sense of urgency, attention to detail, teamwork, and cross-functional collaboration
• Proficiency utilizing MS Office products and working knowledge