Project Specialist - Technology Transfer (Advanced Therapies)

Role Summary

Project Specialist to join the Advanced Therapies Process Sciences team. Provides project management support for the external technology transfer for Antibody Drug Conjugate (ADC) and peptide pipelines, coordinating cross-functional activities to ensure timely transfer of information, methods, and materials for manufacturing.

Responsibilities

• Coordinate IOPS technology transfer core team activities to ensure that all relevant information, methods, and materials are successfully communicated and utilized during manufacturing in accordance with agreed upon timeline.
• Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.
• Take and distribute minutes from meetings.
• Track document approval (e.g., external protocols, records, change requests).
• Generate and review documentation supporting technology transfer (e.g., process descriptions, memos, protocols and reports, as appropriate).
• Coordinate and participate in investigations associated with tech transfer activities.
• Manage document exchange during transfer.
• Reviews controlled document content updates (e.g., MRs, SOPs) to ensure harmonization across production suites.
• Prepare, distribute and present project status reports to project team members and management.
• Represent Process Sciences at various site-wide cross functional meetings.
• Support growth of the organizational process assets (lessons learned depository, risk register, templates, etc.).
• Travel may be required in support of tech transfer activities.
• Participate in continuous improvement initiatives and special projects as assigned.

Qualifications

• BS/BA in a scientific discipline; chemistry or biology preferred.
• Associate Project Specialist: 0-2 years of relevant experience
• Project Specialist: 2+ years of relevant experience
• Sr. Project Specialist: 5+ years of relevant experience
• Willing and able to work Monday-Friday, 8am-4:30pm.
• Level determined based on qualifications relevant to the role.

Skills

• Working knowledge of Microsoft Suite (Word, Excel, PowerPoint) and MS Project.
• Basic understanding of manufacturing processes for monoclonal antibodies/therapeutic proteins and cell and/or gene therapy products.

Education

• BS/BA in a scientific discipline (preferred).

Additional Requirements

• Travel may be required in support of tech transfer activities.