DOMINIC LEPERI

- EXTERNAL ROLE: Demonstrated efficiency in executing end-to-end Project Manager duties for overseeing AA Testing and MRL CB MFG processes at different CMOs to support ongoing FIH programs.

• Accountable for managing and delivering all externally sourced cell banking projects in a multi-dimensional, cross-functional setting.
• Requested and reviewed SOWs/COs for outsourced tasks, such as cell bank manufacturing, testing, LTS, and shipments.
• Maintained responsibility for finance oversight activities such as PO issuance, invoicing, budget forecasts, and FAST updates.
• Facilitated efficient communication between CB MFG and CMOs, ensuring timely updates and deliverables. Troubleshoot issues when necessary, and communicate outcomes to stakeholders.
• Requested MFG slots, selected top clones, and authorized testing activities.
• Conducted pre-execution CBR reviews to identify potential manufacturing issues and rectify them before the start of production.
• Implemented updates to protocols, manufacturing, and testing facilities resulting in improved efficacy of existing filings (CCs).
• Led routine Merck-CMO meetings for monitoring project progress and updates
• Oversee and administer current CB initiatives
• Ensured project teams were updated on current CB milestones through communication with CB Technical Lead (PCS).
• Engaged in pre-audit/post-audit/CoC/Governance meetings with CB MFG CMOs (Azenta, CRL,
  BioReliance,
  WuXi Advanced Therapies,
  WuXi Biologics) to effectively address quality and technical matters
• Supported IACUC approvals for animal-based testing at external CMOs, when applicable.

- INTERNAL ROLE: Managed and oversaw end-to-end project activities, including MRL CB MFG and AA Testing. Deliver all goals on time.

• Led weekly internal meetings to monitor project progress, updates, and obstacles.
• Supported ownership transfer of late stage programs to MMD, collaborating with PCS and BVDQ.
• Participate in monthly MRL-MMD Tactical meetings to support CB MFG/Testing. Participated as a core member of the Cell Bank Working Group that was set up in 2024.
• Supported E2E CB Transformation Workstream.
• Delivered biweekly progress reports to project teams.
• Developed clear R&R guidelines for current and prospective CB MFG/Testing operations.
• Facilitating stakeholder involvement in the E2E workstream.

• Oversee independent CLD project timelines for timely milestone delivery on all FIH projects in alignment with CMC/DCT team goals.
• Demonstrated proficiency in basic cell culture techniques to follow platform process for evaluation of potential candidate cell lines.
• Managed and executed independent, individual CLD project timelines and high-quality deliverables in alignment with CMC/DCT team goals.
• Res
• Led team of up to 3 Scientists in the Flow Cytometry core group between 2020 and 2023.
• Achieved project management success through independent execution of CLD projects with continuous adherence to CMC/DCT guidelines
• Consistently delivered milestones on time or ahead of schedule for all FIH projects.